Senior Manager Or Associate Director/Director, Regulatory Affairs
Sam Whyley-Smith at CK Clinical is recruiting for a Senior Manager or Associate Director/Director, Regulatory Affairs to join a Global Contract Research Organisation (CRO) based in London, UK or Munich, Germany on a permanent basis. The level of the role offered is dependent on the candidates experience.
Our client is a scientifically-driven global CRO with an excellent reputation for providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.
Key responsibilities will include:
- Develop and review regulatory submission documents in support of clinical trials with a specific focus in providing Advanced Therapy Medicinal Products (ATMP)/ Genetically Modified Organisms (GMO) advice and dossier compilation;
- Developing, tracking, compiling, and maintaining full regulatory applications including Paediatric Investigation Plans (PIPs), Orphan Designations, and Market Authorisation Applications (MAAs);
- Maintaining timelines for full regulatory submissions;
- Providing regulatory advice and guidance to Sponsors and other departments to ensure compliance with UK and European regulations and requirements;
- Developing scientific and regulatory briefing documents for meetings with the EMA;
- Interaction with EMA, MHRA, and other regulatory agencies;
- Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.
- Bachelor's degree and demonstrated regulatory affairs experience;
- Knowledge of Advanced Therapy Medicinal Products (ATMP) is essential with Genetically Modified Organisms (GMO) experience being highly desirable;
- Experience with EMA and other regulatory agencies is preferred;
- Strong computer skills, project management skills, and a high attention to detail;
- Strong communication skills (both written and oral);
- Must be a team player with a global regulatory mind-set;
- This position may require supervision of junior level staff.
Travel: Less than 30%
For more information or to apply for this position, please contact Sam Whyley-Smith on 01246 580040 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46334 in all correspondence.