Affiliate Lead, Regulatory Affairs - South Africa

About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. 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 work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. The Opportunity: As the Affiliate Lead, Regulatory Affairs, South Africa, you will be reporting directly to the Head, Regulatory Affairs, Turkey Middle East Africa (TMEA) and manage and lead the affiliate RA (Regulatory Affairs) department and staff (including back-up) with the overall responsibility for all Marketing Authorizations (MA)/product registrations in scope of the affiliate. 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. Responsibilities:

1. 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.
2. Maintain licenses with the SAPC, (South African Pharmacy Council), SAHPRA (South African Health Products Regulatory Authority) and DoH (Department of Health) in line with local regulations.
3. Oversee the handling of complaints, returned and rejected goods, product release, vendor audits, adverse events and GxP in collaboration with the QA and PV functions.
4. If necessary, handle medicines recall according to SOP. Inform SAHPRA immediately of any possible withdrawal of unwanted medicine from the market.
5. Ensure liaising between regional RA, the affiliate Management Team (MT) and the competent authorities. Be the key contact for the competent authorities.
6. Implement locally new initiatives, management tools or processes in cooperation with regional RA. Ensure that all affiliate RA staff has access to the necessary tools and systems.
7. As Code Compliance Officer, approve material and interactions in line with the Marketing Code.

Essential Knowledge & Experience:

1. Substantial experience in Regulatory Affairs in the pharma industry, including directly dealing with regulatory agencies.
2. Knowledge of the Marketing Code of Practice.
3. Eligible for registration as a Responsible pharmacist at the South African Pharmacy Council.
4. Knowledge of the Regulatory landscape and procedures within South Africa.
5. Cross-functional collaboration and communication both at the affiliate and HQ level.
6. Knowledge of the Medicines Act, Pharmacy Act, and applicable regulations.

Preferred Experience:

1. Good communication, influential, planning, and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholders.

Education:

1. MS Degree in Pharmacy or other Life Science or equivalent.
2. BPharm registered with the South African Pharmacy Council.

Additional information:

1. This is a permanent, full-time position.
2. The position is based in Johannesburg, South Africa.
3. Candidates should be based in Johannesburg, South Africa.
4. This position follows our hybrid working model. Role requires a blend of home a minimum of 2-3 days in our Johannesburg office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.

What We Offer:

1. A challenging and diversified job in an international setting.
2. Opportunity and support for continuous development.
3. 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. Job Types: Full-time, Permanent #J-18808-Ljbffr