Affiliate Lead, Regulatory Affairs - South AfricaLocation: South AfricaFunction/Business Area: Regulatory AffairsDepartment: Medical DepartmentEmployment Class: PermanentDescriptionAbout Astellas: At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others. Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It's a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners. 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. Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity. We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.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: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.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.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.If necessary, handle medicines recall according to SOP. Inform SAHPRA immediately of any possible withdrawal of unwanted medicine from the market.Ensure liaising between regional RA, the affiliate Management Team (MT) and the competent authorities. Be the key contact for the competent authorities.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.As Code Compliance Officer, approve material and interactions in line with the Marketing Code.Essential Knowledge & Experience:Substantial experience in Regulatory Affairs in the pharma industry, including directly dealing with regulatory agencies.Knowledge of the Marketing Code of Practice.Eligible for registration as a Responsible pharmacist at the South African Pharmacy Council.Knowledge of the Regulatory landscape and procedures within South Africa.Cross-functional collaboration and communication both at the affiliate and HQ level.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:MS Degree in Pharmacy 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 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: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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