At Astellas, experience is coupled energised with a relentless challenger spirit.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation.
We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers.
We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients.
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:
• Substantial experience within a similar Regulatory Affairs role ideally with a global pharma organization in South Africa.
• Eligible for registration as Responsible pharmacist at the South African Pharmacy Council is mandatory.
• Knowledge of Regulatory landscape and procedures within South Africa
• Knowledge of the Marketing Code of Practice.
• Knowledge of the Medicines Act, Pharmacy Act and applicable regulations.
Preferred Experience:
• Good communication, influential, planning and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholders.
Education:
• BA/BS Degree in Pharmacy, Medical or other Life Science, or equivalent
• BPharm registered with the South African Pharmacy Council
Additional information:
• This is a permanent, full time position
• The position is based in Johannesburg, South Africa
• Candidates should be based in Johannesburg, South Africa
• This position follows our hybrid working model. Role is blend of work from home and a minimum 2 days in Johannesburg office. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
What We Offer:
• A challenging and diversified job in an international setting.
• Opportunity and support for continuous development.
• Inspiring work climate.
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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