Regulatory Affairs Manager

2 weeks ago

High Wycombe, Buckinghamshire, United Kingdom newscientist - Jobboard Full time
Job Title: Regulatory Affairs Manager

We are seeking an experienced Regulatory Affairs Manager to join our team at ClinChoice, a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

About the Role

The successful candidate will be responsible for supporting the EMEA Regulatory Affairs team with post-approval activities for MRP/DCP products across the EEA and coordinating work-sharing procedures for CMC and non-CMC variations. They will also support the team with regulatory activities for European procedures, such as Decentralized, Mutual Recognition, and Work-Sharing procedures.

Key Responsibilities
  1. Support the EMEA Regulatory Affairs team with post-approval activities for MRP/DCP products across the EEA.
  2. Coordinate work-sharing procedures for CMC and non-CMC variations.
  3. Support the team with regulatory activities for European procedures, such as Decentralized, Mutual Recognition, and Work-Sharing procedures.
  4. Prepare and compile regulatory submissions, responses to Regulatory Agency questions, and other correspondence in accordance with EU regulations and guidelines.
  5. Ensure compliance within the department by maintaining EAME databases (RegPoint, HAQ).
  6. Support the EMEA RA team with consolidated Calls for Information (CFI) and coordinate submission of PSUSA.
  7. Provide regulatory advice and perform due diligence for product acquisitions and distributor agreements with third parties.
Requirements
  1. Maintain awareness and knowledge of current regulatory legislation.
  2. Ensure regulatory best practice at all times.
  3. Monitor changes in the regulatory environment and highlight any potential impact on products.
About ClinChoice

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and a supportive culture. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

We are committed to contributing to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and we are dedicated to attracting, developing, and promoting talent guided by diversity and inclusivity.

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