Affiliate Lead, RA South Africa

About This Job :

As the RA Affiliate Lead, South Africa, you will be reporting directly to the RAPV Sub-Regional Lead, Turkey Middle East Africa (TMEA) and manage and lead Regulatory Affairs (RA) at affiliate level with the overall responsibility for all Marketing Authorizations (MA) / product registrations in scope of the affiliate. This is an individual contributor position and is part of the leadership team in South Africa. You will represent Astellas towards local Health Authorities and pharmaceutical industry associations, where appropriate and act as single point of contact for headquarters and key stakeholders (e.g., Commercial and Medical Affairs, Market Access & Pricing, Quality Assurance, Supply Chain) and represents RA in the affiliate Leadership Team (LT).

Hybrid working :

At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.

Key Responsibilities :

• Fulfil the duties of the Responsible Pharmacist as outlined in the Pharmacy Act (Regulation 25 (3)), Medicines Act (Regulation 16 (2)), Marketing Code of Practice, and applicable guidelines on pharmacovigilance.
• Development and execution of the affiliate RA strategy, planning and objectives.
• Safeguards timely and high-quality management (e.g., change control, preparation and submission to local Health Authorities) of RA dossiers and records in accordance with applicable standard
• Supports proper implementation of RA submission outcomes, including preparation of artworks (printed packaging components) and communication of Product Information to relevant stakeholders
• Attends and facilitates key meetings with local Health Authorities to support development and execution of the RA strategy.

Essential Knowledge & Experience :

Preferred Experience :

Education :

Additional information :

What We Offer :

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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