Job Vacancies at Abbott

THE OPPORTUNITY

This position works out of our Johannesburg offices, South Africa in the ESTABLISHED PHARMACEUTICAL DIVISION . In EPD, We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

As the SENIOR RA  , you will ensure new medicinal products are registered and existing registrations are maintained in accordance with current regulations of each country within the English Africa Cluster (EAC).Ensure promotional material for marketed products complies with the relevant product registration and country-specific Codes of Marketing Compliance.Ensure compliance to Abbott Global and Regional Regulatory Affairs Quality Systems, policies, and procedure

WHAT YOU’LL DO

CORE RESPONSIBILITIES:

REGISTRATION OF NEW PRODUCTS:

• Works in collaboration with the Regional Product Lead (RPL) to proactively assess local submissions requirements, review & sign-off content for registration packages accordingly.
• Conducts dossier due diligence to ensure all data gaps are addressed in preparation for new registration applications.
• Prepares the registration applications for submission to the NMRA in conjunction with the relevant RPL’s.

LEGISLATION, REGULATORY AUTHORITIES & PROCESS IMPROVEMENT:

• Keeps abreast of new developments in legislation, guidelines, and regulations of the NMRAs, interprets and cascades these locally and globally within the organization.
• Liaises   with the   NMRAs and appointed   Agencies on new developments in the registration process, and ongoing activities for registered products.
• Communicates approvals from health authorities to relevant stakeholders
• Identifies and recommends opportunities for improvement to the existing processes, quality, systems, tools, and policies.
• Maintains written procedures are up-to-date.

MAINTAINING EXISTING REGISTRATIONS:

• Prepares and submits technical updates based on the review of current data versus data contained in the registration application.
• Compiles and submits technical amendments based on requests and data received from the registered manufacturing site and I or the RPL.
• Compiles and submits package insert amendments based on revised CCDS received by Area Labelling Coordinator.
• Reviews and approves new artwork and updates to artwork in line with regulatory requirements to be uploaded to the artwork system by RA associate
• Compiles and submits renewal packages for countries where this is required within the agreed timelines to ensure no loss of registration license.
• Reviews and approves promotional material for marketed products to ensure compliance with the relevant product registration and any country-specific Code of Marketing Compliance.

LIAISING INTERNALLY AND WITH OTHER DEPARTMENTS:

• Business Development, Quality Assurance, Medical, Pharmacovigilance, Sales & Marketing, Operations.

MANAGEMENT OF QUALITY DOCUMENTS RELATING TO REGULATORY AFFAIRS PROCESSES:

• Ensures compliance to EPD Global & Regional RA Quality Systems, policies, and procedures.

REQUIRED QUALIFICATIONS

• Bachelors In Pharmacy ( BPharm) OR Masters in Pharmacy ( MPharm) OR Doctor of PHARMACY (PharmD) Degree is Essential – i.e Registered Pharmacist
• Registration with the South African Pharmacy Council (SAPC) is essential

PREFERRED EXPERIENCE:

• 3 - 5 years' experience in the Regulatory Affairs environment
• 1 - 2 years' experience in regulatory activities in English & Portuguese speaking African countries
• Exposure to the marketing of products in the pharmaceutical environments within the EAC
• Project and Portfolio Management
• Knowledge of current legislation governing product registration in English & Portuguese speaking African countries.
• Knowledge of other legal requirements impacting the regulatory environment e.g. advertising, GMP etc.
• Knowledge of pharmacology and therapeutics.
• Knowledge of the Abbott organization, policies, and procedures

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THE OPPORTUNITY

This position works out of our Johannesburg offices, South Africa in the ESTABLISHED PHARMACEUTICAL DIVISION . In EPD, We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

As the HEAD OF REGULATORY , EAC , you will represents the company in dealings with the Registration and Pharmaceutical authorities and ensures compliance with applicable legislation.Directs, organizes and maintains the medicine registration function of the Established Pharmaceuticals Division across all countries within the English Africa Cluster;Advises on all forensic pharmaceutical matters related to these activities.Ensures alignment of department goals to that of the cluster as well as Regional Regulatory Affairs.Manages and oversees all activities conducted by regulatory team and regulatory consultants

WHAT YOU’LL DO

CORE RESPONSIBILITIES:

Regulatory - Medicine Registration Function:

• Provides guidance to regional product leads and commercial functions on regulatory strategies for new product registrations such as Geo-expansion projects and Licence & Acquisition deals. 
• Oversees the compilation and submission of registration dossiers and the necessary additional documentation to relevant local Regulatory Authorities for the purpose of obtaining Marketing Approval in the countries under the responsibility of the English Africa Cluster by regulatory pharmacists and regulatory consultants as follows:
• Evaluation, summarization and compilation of data to obtain approval where possible for new indications requested by Marketing.

REGULATORY – LIFE CYCLE MAINTENANCE

• Oversees maintenance of products for marketability by the company for submitting and  obtaining approval of planned and unexpected CMC changes including formulation changes, manufacturing changes, packaging changes and improved analytical methods to avoid stock ruptures and cancellation of registration.
• Oversees Labelling safety updates to ensure completion in line with global metrics and local requirements
• Oversees Licence Renewals, Retention & GMP renewal activities to ensure licence validity of all registered products before expiry date.
• Oversees Artwork creation and update activities for all printed packaging material for new product registrations and existing licences.
• Oversees licence cancellation and withdrawal activities in line with internal processes and NMRA requirements
• Oversees local and global regulatory projects to ensure regulatory milestones are met on time
• Oversees the management of Regulatory Risks to reduce and /or mitigate supply & compliance risks

 REGULATORY - REVIEW & APPROVAL OF PROMOTIONAL MATERIAL:

• Oversees review and approval of promotional material to ensure compliance with the registration dossier, Abbott's Marketing Code as well as the relevant local Marketing Codes including the South African Code of Marketing Practices.

REGULATORY – SYSTEMS, DOCUMENTATION, RECORDS

• Oversees regulatory databases and systems to ensure team training and compliance
• Oversees the update and maintenance of electronic documentation records to ensure secure accessibility to authorized stakeholders, for various platforms and folders.
• Ensures the protection of regulatory intellectual property by restricting access to authorized personnel
• Oversees local Regulatory SOP maintenance to ensure SOP’s / work instructions are available for all processes and complied with
• Ensures correct processes are followed for sample requests, legal documentation, payments.
• Oversees conversion of manual paper records to electronic records (scanning of dossiers).

REGULATORY - MANAGEMENT OF RA DEPARTMENT:

• Continually assesses and builds on leadership capabilities to effectively lead regulatory team and regulatory consultants
• Ensures that the department activities (internal team members and regulatory consultants) are continually aligned with Abbott 's strategies and objectives.
• Builds and fosters a team that values, recognizes and generates a business­ oriented, customer-focused , high performance culture.

REGULATORY – AUDIT/ INSPECTIONS

• Oversees internal preparations for audit and inspections to ensure regulatory department is in a constant state of readiness for life cycle activities, dossiers, artwork, promotional material, SOP’s and other documentation.
• Oversees corrective and preventative actions, and effectiveness checks for regulatory related audits and inspections, and provides updates to relevant inspectors, auditors or functional leads.

REGULATORY - LEGISLATION & REGULATORY AUTHORITIES:

• Keeps abreast of new developments in legislation, guidelines and recommendations of the various Health Authorities.
• Oversees the regulatory intelligence process to ensure all stakeholders are kept informed of regulatory changes and requirements and implemented timeously. 
• Attends meetings with respect to new developments in the Pharmaceutical industry , particularly in the Regulatory Affairs and Quality Assurance arenas.
• Liaises with the Health Authorities and, where necessary, their appointed Agencies
• on new developments in the registration process.
• Regulatory - Liaising internally and with other departments:
• Liaises with Business Development, NPI & Marketing on new product registrations requirements and preliminary commercial activities to ensure timely submission, approval and launch. 
• Liaises with Medical I PV colleagues regarding changes to registered package inserts & safety notifications, and any queries or requests related to regulatory activities.
• Liaises with the sales & marketing to advise on registration, and quality status of their products and to provide guidance on promotional activities.

REGULATORY – LIAISING WITH EXTERNAL STAKEHOLDERS

• Oversees and communicates with legal technical representatives during regulatory landscape meetings to track submissions and regulatory updates from NMRA’s, and for ad hoc queries
• Oversees and communicates with health authorities, third party suppliers / service providers, licence and acquisition partners and trade associations as required.

COMPLIANCE CHAMPION – EAC

• Ensure 6 steps of the compliance program are executed in line with agreed metrics
• Collaborate with OEC on compliance activities and relevant communication to affiliate
• Oversees Contract Maintenance process for affiliate to ensure cross-functional processes are followed and contracts are compliant with the provisions of Pharmacy & Medicines Acts

ASSIST AND PROVIDE SUPPORT TO THE QUALITY DEPARTMENT.

REQUIRED QUALIFICATIONS

• Bachelors In Pharmacy ( BPharm) OR Masters in Pharmacy ( MPharm) OR Doctor of PHARMACY (PharmD) Degree is Essential – i.e Registered Pharmacist

PREFERRED EXPERIENCE:

• 5 - 7 years' experience in the Regulatory Affairs within the pharmaceutical industry
• Minimum 3 years' experience managing a team of staff
• Exposure to the marketing of products in the pharmaceutical environment
• Project I Portfolio Management

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THE OPPORTUNITY

• This position works out of our Johannesburg offices, South Africa in the Abbott Molecular Division (AMD ) . In AMD, we focus on molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level and are committed to are committed to advancing molecular testing solutions that guide life’s most profound decisions.
• As the DEMAND PLANNER, you will be responsible for the short and mid-term demand planning and driving the operational excellence in demand.

WHAT YOU’LL DO

• Demand Planning: own the demand forecast process, consolidate the country demand forecasts in sales and units and develop a realistic demand plan for Africa. Anticipate when to act and provide supporting detail to reach consensus on the demand forecast, identify and articulate issues and decisions that need to be addressed in the IBP meeting. Challenge forecast assumptions, ensure the demand forecast is integrated into and synchronized with the financial plans, continuously monitor variables affecting demand, collect and report rationale for variances and deviations to target.
• Takes accountability and ownership of the Sync Chart process for Africa Liaising with Delkenheim and Des Plaines for Direct Shipment
• Forecasting Accuracy: drive accountability for demand forecast accuracy in the region through KPI reporting and feedback to process participants.
• IBP Process: Aligns with Managing Director and Commercial Excellence on the Integrated business planning {IBP) process with senior management and cross-functional teams across Africa through monthly Demand Review meetings.
• Overseeing processes in delivery of the month/ quarter: analyze the demand for the month/ quarter and work closely with Supply Chain team, Head of Commercial Excellence and Managing Director to ensure sales commitments can be met. Creates and manages area or country product/shipment allocations during times of short supply.
• New product launches support the development of new product launches and retirements plans
• Communication: support management team in demand planning and forecasting accuracy improvements, develop and maintain communication links between finance, marketing, sales, and commercial excellence to ensure proper execution of the forecast
• KPI management: develop, maintain, and constantly improve processes and performance measures for Africa
• Funder Demand: Attend all funder calls and provides input on all demand related questions
• Funder Demand: Ensure that Abbotts demand aligns with funder contracts ensuring Africa is always within the OTIF, KPI stipulated by funders in their SLA
• Weekly reporting on Demand for region Africa and ensuring no stock out in any country
• Develops and implements programs to help the field be more efficient and allow sales team to be more time in front of customers
• Africa Growth Charts / KPI tracking reports on monthly basis
• Work through the Synch chart on monthly basis to ensure the supply can cater for Other Africa needs
• Manage the stock assignment with SNR Commercial Analyst, EMEA and Head of  Commercial to get the needed stock requirement in-route to South-Africa
• Ensure Stock recons
• Understand customer expectations on KPI's, provide visibility to their scorecards internally and deliver on customers' KPI expectations wrt demand
• Collaborates with key stakeholders and those who influence service performance; including Commercial teams, Supply Planning, freight, and warehousing service providers to address ways to improve customer satisfaction
• Back Order management – and ongoing feedback to sales team

REQUIRED QUALIFICATIONS

• University Degree in Supply Chain and or logistics, or equivalent business experience

PREFERRED EXPERIENCE

• 4 years experience in a Snr Demand planning role
• Excellent MS Office skills, especially Excel and Power Point
• Strong interpersonal and communication skills with ability to communicate across all organizational levels, confident presenting to senior management
• Enjoy working independently in an agile business environment
• Office based
• Accountability and Ownership of Demand Process     
• Long-term, strategic focus on global account relationship in terms of demand planning: Chemonics, Global Fund, UNDP, UNICEF
• Travel up to 30%
• Fluent in English

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As the HEAD OF MEDICAL, EAC ,  Develop and maintain in depth knowledge for assigned product(s) / relevant therapeutic area(s) through attendance / participation at key internal meetings/training sessions, relevant congresses, and seminars and by regular self-study of the national/international literature.Provide expert medical/scientific advice for assigned products and related therapeutic areas, including responding to requests for scientific/technical information; contribute to the development and medical and scientific accuracy of core dossiers generated by the medical department (i.e. pricing and reimbursement dossiers, HEOR dossiers, medical information packs, clinical expert reviews etc.).

WHAT YOU’LL DO

• Ensure that all activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, company policies and accepted standards of best practice.

KOLs Management and development;           

• Develop & maintain professional and credible relationships with key opinion leaders and academic centers to ensure access to current medical and scientific information on the products and areas of therapeutic interest.  
• Develop & maintain scientific expertise of company products and related therapeutic areas.
• Foster collaboration and partnering between opinion leaders and the company.
• Obtain feedback and advice about company products through peer-to-peer interactions and advisory boards.
• Identify and develop speakers for the company’s TAs & products.
• Identify investigators appropriate for clinical trials.
• Act as a conduit for unsolicited, investigator-initiated research proposals by facilitation proposal, approval, completion, presentation, and publication of studies

• Keep abreast of cutting edge research and literature in therapeutic area.        
• Assist in the initiation, oversight and follow up of assigned clinical studies and medical projects initiated within the relevant therapeutic area of Abbott (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV), IIS projects, etc.): all activities to comply with applicable local laws, guidelines, codes of practice, SOPs, and Global Pharmaceutical Research and Development (GPRD) SOPs.
• Ownership of pre-launch medical activities (BD, new products assessments, market research program, advisory boards, experts’ insights meetings…)
• Conduct medical and product training for medical representatives (Initial training, Refreshment sessions, preparation of quizzes and assessments of all TAs)
• Ownership of Pepper System, supervision and follow-up on the review and approval of medical / scientific promotional materials till the release to the market.
• Deliver credible presentations on scientific matters to physicians (individually or in groups meetings, clinical sessions, RTDs etc.), where requested.
• Participate in the selection process to identify appropriately qualified physicians the Company would wish to engage in collaborative efforts – such as potential research collaborations, or lecture/meeting support (Round Tables, Congresses, Symposia, etc.); and to ensure a high level of scientific or educational integrity in these collaborative efforts.
• Ensure Proper documentation for various medical activities; PSAs, Medical Research & Sponsorships.
• Assist in developing awareness and understanding of competitor issues/intelligence – for example, product strategies, studies, commercial messages, positioning, etc – and communicate, where appropriate, within the Company.
• Attend relevant Scientific Societies meetings and Conferences, and develop summaries of key messages for use within the Company – such as key areas of scientific/company interest, new trends in diagnosis, monitoring and treatments in the therapeutic area, etc.
• Upon request, assist physicians to appropriately direct requests for access to Company products on a named patient or compassionate use basis, subject to all applicable legal and regulatory requirements.
• Support sales/marketing/internal team areas to develop their scientific and technical expertise through the delivery of scientific update presentations.
• Ensure up to date knowledge of products uses and external data.
• Provide key opinion leaders and internal medical and clinical teams with scientific and technical support for publications of scientific or medical interest.
• Deliver scientific presentations and medical education programs to healthcare professionals individually or in groups where requested.
• Screen relevant literature and other information from relevant scientific societies meetings and conferences and develop summaries of key messages for use within the Company.
• Deliver training to sales forces and other departments and develop and update relevant training materials.
• Review and preparation of promotional material.
• Ensure the medical/scientific content is correct and fully compliant with Abbott’s internal policies and guidelines.
• Identify new business opportunities within areas of therapeutic interest in the company
• In field visits to healthcare professionals with and without representatives
• Backup Affiliate Safety Representative.
• Duly fulfil all the requirements of the Affiliate Safety Representative when they cannot perform their duties

Support Pharmacovigilance Responsibilities:

• Liaises with Health Care Professionals to obtain as much information as possible with respect to adverse events associated with Abbott products
• Records, reports and tracks all adverse events, both serious and non-serious, to GPV and local health authorities in the time   frames as required by the relevant company SOP’s and current legislation
• Trains all new sales, marketing and affiliate staff on matters pertaining to Pharmacovigilance
• Tracks submission of PSUR’s
• Documents the receipt of all external queries for safety information in collaboration with the Medical Advisor.
• On a daily basis review all global adverse events appearing in the OSYRIS work flow
• Advise OSYRIS Management of any changes required

REQUIRED QUALIFICATIONS

Bachelors Degree in Medicine (MBChB) is essential – i.e a registered Medical Doctor

And OR Bachelors In Pharmacy ( BPharm) OR Masters in Pharmacy ( MPharm) OR Doctor of PHARMACY (PharmD) Degree is advantageous

PREFERRED EXPERIENCE:

• A minimum of 3 years within similar roles.
• 5 years’ experience with the Pharmaceutical industry preferably having worked within the Emerging Africa Markets.
• Experience working in a pharmaceutical industry and general knowledge of drug development and clinical research
• Experience in Scientific report writing would be advantageous
• Skills in administration, planning and organizing essential
• Ability to work under pressure.
• Experience working in a pharmaceutical industry and general knowledge on drug development and clinical research an advantage.
• Candidate should be customer and patient oriented while having the ability to build strong relationships with stake-holders and other relevant KOL and Parties.
• Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity.

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This position works out of our Johannesburg location in the Abbott Rapid Diagnostics Division.  In this division our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges.

The role of RA intern will be instrumental in supporting of  regulatory matters of our Abbott Rapid Diagnostics Division across the continent of Africa. The candidate will learn about the evolving regulatory environment of medical devices and work with the team to ensure that Africa RA  milestones are achieved and aligned to meeting of company commercial objectives.

WHAT YOU’LL DO

• To co-ordinate and ensure execution of regulatory submissions and communication to country stakeholders of assigned product changes that are implemented in the affected countries.  
• Be a liaison between Global RA teams and local teams in communicating on the ongoing status of project changes until approval is attained for compliant import of the changed version of product.
• Support the RA Lead in Health and Safety administrative compliance matters for the site and will assist in the coordination of the activities pertaining to the implemented medical surveillance program.

REQUIRED QUALIFICATIONS

• Bachelor’s degree ( BSc)  in Science.
• Basic skills in Microsoft Excel, Word and PowerPoint

PREFERRED QUALIFICATIONS

• NO experience is preferred- i.e. the organization is seeking to hire newly graduated candidates.
• Must live in Johannesburg
• Strong command of the English language - both verbal and written skills
• Good communication skills
• Good organizational skills
• Expected to work with tight deadlines