Together, were on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. Its a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the worlds leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organizations Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but were always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
We are currently recruiting for a Regulatory Affairs Pharmacist to join our Regulatory Affairs team in South Africa on a Full Time, Permanent basis.
How Youll Spend Your Day
- Assist with the submission of new product applications in South Africa and Sub-Saharan Africa
- Submit responses to new product and backlog application resolution letters from SAHPRA and Sub-Saharan African regulatory authorities
- Submit product variation or amendment applications in accordance with the relevant legislation, regulations and guidelines in South Africa and Sub-Saharan Africa
- Ensure approval of new product submissions and amendments
- Creation, review and approval of artwork and printed packaging
- Review and approval of promotional material
- Establish and maintain effective relationships with all internal stakeholders
- Establish and maintain effective relationships with external stakeholders
- Maintain regulatory systems/programs and tracking as required locally and by global.
- Support other key functions within the business (supply chain, QA, marketing etc.)
- Remain abreast of new legislation, guidelines and developments impacting on the regulatory environment
- You will hold a B. Pharm degree and be registered with the South African Pharmacy Council as a practicing pharmacist
- You will have a minimum of 3 years regulatory affairs experience - preferably working with Sub-saharan African countries
- You will have good knowledge of artwork processes and approvals as well as e-CTD and e-submissions
- Experience working with innovator and/or generic products is an advantage
- You will be a self-motivated and proactive individual with good analytical and project management skills
- Above all, you will be a great team player who works collaboratively and cross functionally when required
Associate Director - Regulatory Affairs
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Tevas Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
