Senior Regulatory Manager
An exciting job opportunity has arisen for a Senior Regulatory Manager to join a leading worldwide, research-based pharmaceutical company based in London. The company has over 30,000 employees worldwide, with products that include treatments for diabetes, cancer and asthma.
- Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs and/or oversight of marketed product support, while maintaining full compliance with applicable regulatory requirements. Effectively communicates objective assessments of the likelihood of success of these regulatory strategies.
- Provides a regulatory expertise and strategic focus for assigned development projects and /or marketed product life cycle management.
- As Regional Lead, may be called upon to act as deputy to the Global Regulatory lead, attending internal team meetings, as appropriate.
- Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to project areas and/ or region of responsibility enabling proactive approach and planning.
- Primary contact with health authorities for project(s)/products of responsibility in regions of responsibility, or can delegate to staff and/or vendor with oversight. Informs the business.
- Leads the regulatory working team for own region and represents region as needed at project team and ensures regional regulatory lifecycle management strategy and submission planning written and executed according to plan - or oversees if delegated to staff and/or vendor.
- For the project(s)/product(s) of responsibility, collaborates with Global and Regional colleagues for the authoring of global regulatory strategies and ensures own critical deliverables as agreed within the global regulatory strategy and planning.
- Where responsibility includes a marketed product, provides oversight to ensure regulatory compliance, including oversight of the product related data in the registration database.
- Accountable for working with other functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within region (s) of responsibility (E.g. EMA submissions for Europe).
Skills and Requirements:
- BSc degree or equivalent in science; advanced degree preferred.
- Considerable pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and /or post-marketing phases.
- Sound working knowledge of regulations and guidances governing drugs and biologics in development, including post-marketing in the US and/or EU (relevant to role). A good understanding of basic regulatory requirements in emerging markets is a plus.
- Understands and interprets complex scientific issues and capability to relate to regulatory requirements and strategy.
- Proven regulatory submissions capability in a region (Europe, US, EM).
- Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Able to demonstrate skill(s) in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- Generally strong in working well with others and within global teams.
- Effective manager who is able to bring working teams together for common objectives.
- Experience managing relationships with CROs and/or contractors preferred.
- 20%, some international required.
- 6+ years of pharmaceutical industry experience. This is inclusive of 5 years of regulatory experience or combination of 6+ years regulatory and/or related experience.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call David Nixon on or upload your CV on our website - .
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.