Johnson & Johnson
Regulatory Affairs Consultant
Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.
We are currently recruiting for a Regulatory Affairs Consultant to join our contingent workforce.
- Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within the relevant therapy area
- Responsible for regulatory activities related to National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
- Define regulatory strategies (local and regional) in line with business plan.
- Complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
- Prepares and compiles regulatory submissions (Marketing Authorisations Applications, Renewals Variations, Reclassifications etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU & UK regulations and guidelines.
- Sign off packaging material, leaflets, SmPCs and advertising material (as appropriate) to ensure regulatory compliance for submissions
- Ensure Marketing Authorisations are maintained and renewed, and sunset obligations are met
- Ensures compliance within the department by ensuring Global, EAME and local databases are fully maintained.
- Processes, SOPs, working instructions and Job Aids are adhered to.
- Update relevant local and global databases to track current product information.
- Maintain awareness/knowledge of current regulatory guidance and legislation, in particular related to Brexit
- Monitor changes in the regulatory environment and highlight any potential impact on McNeil Products Ltd / J&J products.
Experience and Key Competencies:
- Life sciences or chemistry graduate to honours level or equivalent.
- Must have UK market regulatory experience within pharmaceutical regulatory affairs and working with MHRA directly, ideally with some OTC experience
- Brexit related regulatory knowledge and experience
- Must have hands on experience in management of day to day UK and EU regulatory procedures
- Ideally knowledge and experience of allied regulatory affairs areas such as Cosmetic, Medical Devices but not essential
- Works with minimal supervision to plan, conduct, and manage regulatory submissions and multiple projects to meet department and company objectives.
- Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity including processes
- Project management, understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations etc