Duties and responsibilities
Applicants will have extensive experience in all or most of the following areas:
- Preparation, submission, and maintenance of Clinical Trial Applications in the EU and UK.
- Strategic and tactical input in development, post-approval, and lifecycle management projects.
- Liaison with regulatory agencies, client companies and other stakeholders
- Schemes such as orphan drug designation, SME status, paediatric. investigation plans, scientific advice, ATMP classification, PRIME, EAMS and ILAP.
- Marketing Authorization Applications and post-approval procedures.
Experience
- In depth knowledge of the regulatory environment, guidelines, and practice within the EU.
- Experience in the clinical development and/or biotech sectors are particularly desirable.
Qualifications
- Bachelor’s degree in pharmacy, a life science, or a biomedical discipline.
Personal attributes
- Excellent English and written and oral communication skills.
- Excellent project management, organization, and multi-tasking skills.
- Superb attention to detail and accuracy.
- Self-motivated, pro-active, and capable of working independently and as part of a team.
Successful applicants will be competent in the following
- Fostering constructive and professional working relationships with clients.
- Delivering on projects on time and within budget.
- Keeping up to date with new or changing regulatory requirements in relevant territories.
- Managing multiple projects and priorities.
Location
- The position of Senior Regulatory Affairs Manager will be fully remote based in the UK.