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.

Responsibilities:

• 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