Johnson & Johnson Careers
Senior Regulatory Affairs Executive
Requisition ID: 1905741008W
A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.
Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.
We are looking for a Senior regulatory affairs executive to work on a range of products across our consumer portfolio which includes Cosmetics, OTC and medical devices. You will be responsible for Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area.
- Supporting regulatory
activities for National and/or European procedures (Decentralised, Mutual
Recognition) as appropriate.
- Developing and support
regulatory strategies (local and regional) in line with business plan.
- Completing regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met.
- Preparing and compiling
regulatory submissions (Marketing Authorisations, Reclassifications etc.),
responses to Regulatory Agency (RA) questions and other correspondence in
accordance with EU regulations and guidelines.
Signing off packaging material, leaflets, SmPCs and advertising material to ensure regulatory compliance for submissions via Zinc, COCOON, Starfish systems etc.
Ensuring Marketing Authorisations are maintained and renewed.
Informing the Regulatory Agency/Department of Health (as appropriate) of product discontinuations and licence cancellations.
Providing regulatory advice and perform due diligence for product acquisitions and distributor agreements with third parties.
Do you have the following skills, educational and knowledge requires we are looking for?
- You are a Life
sciences or chemistry graduate to honours level or equivalent.
- You can work independently
to plan, conduct, and manage regulatory submissions and multiple projects
to meet department and company objectives.
- You can work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.
- You have experience in Project management, understanding of regulatory environment, interaction with the Regulatory Authorities, commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applications will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Johnson & Johnson Limited (8700)