Parkside Recruitment
Regulatory Affairs Manager
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About the Company
I am partnering with a mid-sized Pharmaceutical client who are looking for a Regulatory Affairs Manager on a permanent basis working from their new offices in Berkshire. The ideal person will have health authority experience and has been involved in national route submissions. This is a really great opportunity to be part of a high-performing team and an exciting time to be joining the business with several new products coming to market.
About the Role
Your main responsibilities will involve:
- Responsible for UK-specific regulatory oversight on marketed products.
- Striving to constantly improve the QRVI systems and processes.
- Representing the RA function within Regulatory leadership meetings, giving expert advice on strategies to maintain/improve quality performance.
- Managing the Regulatory team to ensure that the Affiliate is in line with the MHRA and European Guidance on any regulatory activities for all relevant products.
- Reviewing and approving documents that directly affect RA activities.
- Project lead and manage all Regulatory activities, for example:
- Scientific Advice meetings
- PIPs
- Orphan Drug designations (ODDs)
- New Registrations via National or Centralised Procedure
- Life-cycle management
- Implementation of EU Regulatory Strategy to maintain the organisation's existing product licenses, and to integrate newly approved products into the portfolio
- Management of overseas Affiliates and other Partners
- Preparing or authoring commercial and post-approval submissions
- Representing the company in communications and meetings with health authorities.
- Negotiating with regulatory authority personnel to expedite approval of pending registrations and respond to queries.
- Assessing the impact of new regulations.
- Managing regulatory documents.
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Requirements
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- Autonomous and independent work, hands-on.
- Good knowledge of and experience in regional regulatory environment in relevant product area and development stage.
- Technically, you will have good working knowledge and experience of:
- Registrations and Post marketing activity; CTD/Dossiers for MAAs (ideally, knowledge of all Modules 1 to 5).
- National Submissions and Centralised Procedure.
- Post marketing: Type Ia, Ib and II variations and renewals; labelling, PILs, and SmPCs.
- RTQs with EMA and MHRA.
- Practical experience in interacting with and influencing the MHRA.
- Possess good commercial awareness, a solid understanding of how the business works, and possess an excellent eye for detail.
- Demonstrated commitment to scientific and regulatory integrity, quality compliance.
- Regulatory and quality expertise to prepare regulatory assessments, develop and contribute to global regulatory strategies with assistance from management for projects across all aspects of drug development or manufacturing lifecycle.
- Excellent planning, organizational, and project management skills.
- Advanced skills in written and verbal communications.
- Competent working knowledge of computer-based systems, such as Microsoft Office, controlled documentation systems.
- Experience in process mapping and writing process documents and driving continuous improvement.
- Flexible approach, readily adapting to changing circumstances and new opportunities; encourages, leads, facilitates, and drives change where appropriate.
- Challenges and questions ways of working to seek improved processes.
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