Head of Regulatory Affairs - EAC at Abbott

THE OPPORTUNITY

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 MarketingCodes 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.
• 8.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