Regulatory Affair Manager

Title: Regulatory Affairs Manager

Duration: 6 month

Location: High Wycombe HP12 4PT

Job Description:

UK REGULATORY AFFAIRS - CONTRACTOR
NORTHERN CLUSTER

KEY RESPONSIBILITIES
Management of a product or specified products within a therapy area for OTC Medicines, Cosmetics, Medical Devices and/or Food Supplements
• Principle responsibilities will be within Consumer Health OTC medicines but may also include assisting in regulatory support for other product types such as Cosmetics, Medical Devices and Food Supplements. Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area

• Supports the team with regulatory activities for National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
• Supports the team with regulatory strategies (local and regional) in line with business plan.
• Supports the team to complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
• Prepares and compiles regulatory submissions (Marketing Authorisations, Reclassifications etc.), responses to Regulatory Agency questions and other correspondence in accordance with EU regulations and guidelines.
• Sign off of packaging material, leaflets, SmPCs and advertising material (as appropriate) to ensure regulatory compliance for submissions via the relevant internal systems.
• Ensure Marketing Authorisations are maintained and renewed.
• Inform the Regulatory Agency/Department of Health (as appropriate) of product discontinuations and licence cancellations.
• Ensures compliance within the department by ensuring
• Global, Regional 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.
• Provides regulatory advice and performs due diligence for product acquisitions and distributor agreements with third parties (as appropriate).

Good Regulatory Practice
• Maintain awareness/knowledge of current regulatory legislation.
• Ensures regulatory best practice at all times.
• Monitor changes in the regulatory environment and highlight any potential impact on McNeil Products Ltd / J&J products.

Customer Service
• May act as an ambassador for the Regulatory Affairs department to raise profile of team both internally and externally.
• May represent Regulatory Affairs on cross-functional product/project teams and provides regulatory advice (as appropriate).
• Interactions with Regulatory Agency
• Seek advice when appropriate.
• Respond to requests for further information and queries.
• Resolve any regulatory matters and expedite approval of pending applications.
• Provides regulatory guidance to internal stakeholders, to allow them make key decisions on business critical activities and project feasibility.
• If required, represent client and provide regulatory advice at e.g. joint Company/Trade Association initiatives, Regulatory Agency meetings etc (as appropriate).

Personal Development
• Complete induction programme in line within the defined timelines.
• Develop product and therapeutic area knowledge as needed.
• Ensure that any processes or SOPs/working instructions/ job aids roll outs are actioned in Compliance Wire and within the defined time-line.
• Maintains training record (as appropriate).

SKILLS, KNOWLEDGE; QUALIFICATIONS & EXPERIENCE
• Life sciences or chemistry graduate to honours level or equivalent
• 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.
• May mentor Graduate and Regulatory Executive and provide day to day support (as appropriate).
• 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.