At a Glance
- Tasks: Lead regulatory strategy and manage submissions for innovative pharmaceutical products.
- Company: Growing pharmaceutical organisation with a focus on innovation.
- Benefits: Competitive salary, career growth, and the chance to impact healthcare.
- Other info: Collaborative environment with opportunities to work across diverse teams.
- Why this job: Join a dynamic team and shape the future of pharmaceutical regulations.
- Qualifications: 5-10 years in Regulatory Affairs with strong MAH lifecycle management experience.
The predicted salary is between 60000 - 80000 £ per year.
Walker Cole is supporting a growing pharmaceutical organisation in the search for a Senior Regulatory Manager to join its regulatory team permanently. This is a key role responsible for leading regulatory strategy, Centralised Procedure (CP) submissions, lifecycle management, and due diligence activities across a diverse portfolio of pharmaceutical products in the UK & EU markets. The ideal candidate will combine strong experience in innovative / specialty products with solid expertise in MAH lifecycle management and regulatory operations.
Key Responsibilities:
- Lead and implement regulatory strategy across UK, EU and international markets
- Manage Centralised Procedure (EMA) submissions, variations, renewals and lifecycle activities
- Lead regulatory due diligence for in-licensing and acquisition opportunities
- Provide regulatory input into product development, launches and portfolio expansion
- Act as a key contact for MHRA, EMA and other regulatory authorities
- Ensure ongoing compliance of Marketing Authorisations (MAH responsibilities)
- Oversee labelling, packaging artwork and regulatory documentation
- Coordinate responses to authority questions, deficiency letters and inspections
- Support cross-functional teams (Quality, Supply Chain, Commercial, BD, Medical)
- Contribute to regulatory governance, SOPs, change control and compliance processes
About You:
- 5–10 years’ experience in pharmaceutical Regulatory Affairs
- Strong experience in MAH environment with lifecycle management (UK & EU MAs)
- Proven experience in Centralised Procedure (CP) / EMA submissions
- Experience in due diligence and in-licensing / acquisition assessments
- Background in innovative and/or specialty pharmaceutical products (advantageous)
- Strong knowledge of MHRA, EMA, ICH guidelines and EU/UK legislation
- Experience managing cross-functional regulatory projects and product launches
- Strong stakeholder management, communication and decision-making skills
- Proactive, detail-oriented and solution-driven mindset
Senior Manager, Data Management employer: Walker Cole International
Walker Cole is an exceptional employer, offering a dynamic work environment within a rapidly growing pharmaceutical organisation. Employees benefit from a culture of collaboration and innovation, with ample opportunities for professional development and career progression in the regulatory field. Located in a vibrant area, the company provides a supportive atmosphere that encourages work-life balance and fosters meaningful contributions to the healthcare sector.
