Shreeya Patel at CK Clinical is currently recruiting for a Pharmaceutical Regulatory Affairs Manager to join a globally successful pharmaceutical company based in the Home Counties.
Pharmaceutical Regulatory Affairs Manager Job Description
As Pharmaceutical Regulatory Affairs Manager you will:
- Support the definition of regulatory strategy and subsequent implementation in the Emerging Markets region.
- Complete lifecycle management activities in line with legal/regulatory requirements and regional business needs.
- Develop and maintain knowledge of Emerging Markets and EU regulatory procedures and contributes to the effective functioning of the Emerging Markets Regulatory Affairs team.
- Build and maintain relationships with Regulatory and other staff within the region to ensure effective communication and efficient implementation of regulatory activities.
- Have line management responsibilities for associates.
- With some supervision support the definition and communication of regulatory strategy in support of new product registration, in line with commercial objectives.
- With some supervision, plan and implement regulatory activities in support of product development, registration, lifecycle management and maintenance in the region.
- With some supervision, provide regulatory support for assigned countries.
- With some supervision, provide appropriate regulatory input to project teams via the Global Liaison and Global Regulatory Teams.
- Ensure effective implementation of the assembly and preparation of core files for Marketing Authorisation Applications, Variations and Renewals for assigned countries.
Qualifications, Skills and Experience:
To be considered for this Pharmaceutical Regulatory Affairs Manager position, you will have the following qualifications, skills and experience:
- Life Sciences Graduate, ideally with post-graduate qualification in a relevant area and/or prior experience in product development functions (pharmaceutical development, toxicology, clinical trials, etc).
- Sound knowledge of principles of Emerging Markets pharmaceutical regulations and guidelines.
- Regulatory Affairs experience, including a successful track record in the registration and maintenance of pharmaceutical products within Emerging Markets region.
- Experience in cross-functional project teams.
How to apply:
For more information regarding this Pharmaceutical Regulatory Affairs Manager position, please contact Shreeya Patel on + 44(0)1438 743 047 or email email@example.com. Please quote reference CL24228 in all correspondence.