Senior Manager, Regulatory Affairs

ProClinical is seeking a Senior Manager, Regulatory Affairs on behalf of a specialist rare disease biotechnology company. This is a contract role based in London, UK.

Job Overview:

This position will be responsible for regulatory activities supporting commercial products and associated CTAs, principally in the EU. Duties for other projects may also be assigned. This position will be required to interact frequently with the regulatory department in the USA and will be based in the London office.

Job Responsibilities:

• Lead management of MAA and provide EU support for Commercial Launch
• Post-authorisation PIP maintenance and the submission of modifications and annual reports.
• Lead REG planning, preparation, and submission of clinical trials
• Support planning, preparation, and submission of MAAs as necessary
• Provide contributions to support product life-cycle strategy.
• Manage interactions with EMA or other regulatory authorities
• Customarily and regularly exercise discretion and independent judgment in the performance of the duties described above.

Skills and Experience:

• 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 (e.g. CTAs, MAAs) 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 drug development regulations and guidelines

To Apply:

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 Peter Duvall on +44 203 0789 542 or upload your CV on our website - www.proclinical.com.

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.