Fresh Jobs at Adcock Ingram

Job Purpose : 

• Timeous new product dossier submission, drive product registration, product life cycle management, compliance and meeting of deadlines set by the Regulatory Affairs Management.
• Compliance with the requirements of the Pharmacy Act (Act 53 of 1974) and the Medicines and Related Substances Act (Act No 101 of 1965 as amended).

Key Job Outputs : 

• Managing the portfolio of products as
• Participate or coordinating all meetings related to the product portfolio and providing RA feedback to the
• Carry out special projects assigned by the RA Manager/Head of
• Ensure timeous initiation and management of the registration process for new product submissions.
• Completes specific pre-registration activities including receipt, screening, compilation, and timeous submission of dossier/s to the Regulatory
• Ensure approval of registration applications of all medicines with the relevant
• Ensure the maintenance/update of registrations in accordance with the relevant legislation, regulations, and
• Receives, prepares, and submits all applicable updates, variations, resolutions, and any other correspondence required by the Regulatory Authority (South Africa and SSA countries).
• Ensures that the Document Database is kept up to date by completing the required administrative activities for appropriate maintenance, co-ordination and accuracy of all dossiers and correspondence.
• Completes dossier audits of Registered Products for the assigned products.
• Conducts dossier due-diligences, post-registration variations for all applicable Regulatory Authorities in compliance with the latest regulatory guidelines and applicable Regulations within the specified timelines to support the business and strategic company objectives.
• Establish and maintain effective relationships with Regulatory Authorities to ensure more effective streamlining of the company’s applications when required.
• Building sustainable relationships with internal and external stakeholders to achieve regulatory goals.
• Prepare, review, and adhere to Standard Operating Procedures (SOP’s) and local Regulatory Guidelines.
• Keeping abreast of developments and changes in the local and international regulatory environments which directly impact Adcock Effectively communicating these changes to relevant stakeholders to assess the impact on the business.
• Supervise and develop other members of the team (RA Associates and RA Grad Students).
• Ensure alignment of personal and company value.

Core Competencies :

• Good verbal and written communication
• Strong detail, quality, and compliance
• Sound project management
• Attention to details and
• Good time
• Proactive, motivated and
• Ability to understand stakeholder needs.
• Output
• Support team cohesion.

Job Requirements

• Bachelor’s degree in pharmacy.
• 3 - 5 years’ experience in Regulatory Affairs, preferably in orthodox, human
• medicines. Biological/Biosimilar experience advantageous/preferred.
• Demonstrable experience across the product development, commercialisation, and life cycle management.
• Knowledge of new and emerging Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
• Experience in use of CTD software builder and compilation of eCTD application will be an advantage.
• Experience and knowledge of SAHPRA electronic platforms and engagement portals.

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Job Purpose : 

• Assist with all systems activities related to the effective growth and maintenance of the Regulatory Affairs Portfolio.
• Identify opportunities within the current and proposed electronic management systems for improving efficiency of the Regulatory Affairs operations.
• Provide support to the Regulatory Affairs Portfolio Leads in terms of maintaining electronic databases, as well as hard copy intellectual property.
• Ensure compliance with the relevant Regulatory Authorities guidelines (country specific where applicable), Medicines and Related Substances Control Act, ensuring timeous processing of electronic regulatory applications and life-cycle management of electronic dossiers and information.

Key Job Outputs 

• Coordinate work streams for the assigned tasks.
• Supporting the eCTD compilation and submission/filing of regulatory activities as per latest SAHPRA & International Drug Regulatory Authority (DRA) guidelines.
• Supporting the eCTD compilation of responses to the regulatory authority committee recommendations timeously and in accordance with guidelines.
• Ensuring that the agreed timelines for approval are continuously being met.
• Ensuring appropriate electronic systems status updates of applications are completed to correctly convey the life-cycle of submitted regulatory activities.
• Coordinate publishing tasks across projects including peer review of applications generated by publishers (e.g., Relicare team).
• Support the team in the planning, development, and publishing of applications.
• Support various internal functional groups ensuring the compliant use of eCTD authoring guidelines, style and conventions. Familiarity with formatting of regulatory application documents ensuring that documentation meets external and internal company submission/application ready standards.
• Perform document management tasks including file transfer, storage, tracking, and archival of Regulatory Affairs application documentation.
• Assist the Regulatory Affairs department members with interpreting SAHPRA, EMA and ICH guidance as it relates to the established eCTD templates, in addition to numerous other submission/filing/application types.
• Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by Health Authorities, ICH and internal working practices.
• Responsible for managing both report level publishing andsubmission compilation for new applications and lifecycle submissions.
• Participate in Regulatory initiatives aimed at improving internal regulatorystandards, systems and procedures.
• Adhere to and participate in implementation of department’s SOPs, RegulatoryGuidelines and Checklists.
• Ensure alignment of personal and company values.
• Departmental Purchase Order creation and submission, including otheradministrative tasks as required.
• Train colleagues and project teams as/when required in relation to theelectronic

Core Competencies :

• Attention to detail.
• Excellent oral and written communication skills.
• Relationship development skills to effectively interact with vendors andstakeholders.
• Drive to succeed.
• Teamwork: Balances team and individual responsibilities; gives and welcomesfeedback; Contribute to building a positive team spirit; Puts success of the teamabove own interests; Supports everyone’s efforts to succeed; Contributes tobuilding a positive team spirit; Shares expertise with others.
• Planning & organising: Prioritizes and plans work activities; Uses time efficiently;Completes administrative tasks correctly, on time without compromising quality(even when under pressure).
• Adaptability: Able to adapt to changes in the work environment; Managescompeting demands; Changes approach or method to best fit the situation; Ableto deal with frequent change, delays, or unexpected events.
• Problem Solving: Identifies and resolves problems in a timely manner; gathersand analyses information skillfully.
• Strategic thinking: Thinking of potential future consequences caused by currentactions within the electronic systems being used.

Job Requirements

• Grade 12 with at least 3 to 5 years’ Regulatory Affairs Operations (or similar) experience in the Pharmaceutical Industry, or Life Science or IT related qualification with at least 2 to 3 years’ Regulatory Affairs Operations (or similar) experience in the Pharmaceutical Industry.
• Strong proficiency with MS-Office Suite and Adobe Acrobat applications.
• Experience in the use of document management tools, understanding of eCTD and regulatory submission requirements, eCTD publishing systems and regulatory management systems is preferred.
• Experience in the use of docuBridge and compilation of eCTD applications is essential.
• Sound project management capabilities.