Quality , Science, Pharmaceutical & Food
Senior Manager – Regulatory Affairs (Hybrid)
- Southern England
PE Global is currently recruiting for a Senior Regulatory Affairs Manager for a leading multi-national biotech client based in London.
This is an initial 12 month contract with the possibility of extension for the right candidate and the client is also offering a hybrid work option.
This position will be responsible as the EU/EEA/UK/CH regulatory lead for one or more marketed products, and will, as necessary, support the EU regulatory leads for the client’s other marketed products in the region. This will involve regulatory activities including management of post-approval commitments, PIPs, PV related submissions, CTAs. This position will be required to interact frequently with the global regulatory team based in California, and will be based in the London office.
- Provide EU/EEA/UK/CH support for marketed products, either as EU regulatory lead or in support of a products EU regulatory lead
- Manage interactions with EMA and other regulatory authorities
- Support planning, preparation, and submission of post-approval submissions
- Post-authorisation PIP maintenance and the submission of modifications and annual reports.
- Lead Reg planning, preparation, and submission of clinical trials applications for post-approval studies
- Support commercial and launch activities
- Provide contributions to support product life-cycle strategy.
- Other duties as assigned.
- BSc degree in life sciences
- Desirable to have at least five-years’ experience in Regulatory Affairs in the biotechnology industry
- Exposure to both development and commercial phases of the product lifecycle
- Proven ability to successfully interact with regulatory authorities
- Experience with Orphan Drugs is desirable
- Skilled at working independently and as part of a team, gathering regulatory information and developing product approval strategies
- Proven ability to manage critical projects as a part of an interdisciplinary team
- Preferable to have experience interacting with regulatory authorities, including helping with the preparation for key regulatory meetings
- Prior experience managing regulatory submissions to ensure successful in time submissions to support the strategic and operational objectives
- Prior experience supporting development of briefing documents
- Thorough understanding of relevant EU regulations and guidelines
- Proficient with computer and standard software programs
- Outstanding interpersonal and communication (written and verbal) skills
- Effective task planning and coordination abilities
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up to date CV to Jennifer.email@example.com
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***