Affiliate Lead, RA - South Africa
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Location and Working Environment
This position is hybrid and will require you to be onsite 2 days per week in JOHANNESBURG, SOUTH AFRICA office.
Astellas’ Responsible Flexibility Guidelines Statement - At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Purpose & Scope
- 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).
Role and 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.
Required Qualifications
- 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.
- BA/BS Degree in Pharmacy, Medical or other Life Science, or equivalent
- BPharm registered with the South African Pharmacy Council
Preferred Qualifications
- Good communication, influential, planning and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholders.
What awaits you at Astellas?
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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