My client are a large CRO based in Central London that work across all phases of the drug development process. They are looking to take on a Regulatory Affairs Manager with strong leadership and technical skills.
- Provide expert regulatory advice to colleagues.
- Ensure submissions are accurately compiled.
- Take part in business development activities including preparing regulatory sections of proposals and feasibility reports.
- Liaise with the Regulatory Director to plan, organise and compile regulatory submissions.
- Coordinate and manage regulatory and ethics submissions through the EMA, Asia Pacific and Latin America regions.
- Review and make recommendations on relevant regulatory documents including labels, SmPCs to ensure compliance with ICH guidelines.
- Previous experience working in a CRO environment.
- Line management experience.
- Strong planning, strategising, monitoring and critiquing skills.
- Strong interpersonal skills in a fast paced, deadline orientated and challenging environment.
- Excellent self motivation skills.
- Make decisions independently.
For more information, or to apply for this Regulatory Affairs Manager position, please contact Meera Pattni on 01438 743 047 or email firstname.lastname@example.org.