The main purpose of this Regulatory Affairs Manager job will be to facilitate product development and global registration by helping to develop regulatory strategy for product manufacturing and quality programs from MAA to life cycle management.
- Preparation of CMC sections for Emerging Markets filings, from MAA to post approval activities.
- Contribute to CMC product teams, reports status and development of projects to teams and department.
- Interact with authors and reviewers with respect to conformance of documents to regulatory and CMC requirements.
- Consider how Emerging Market regional issues effect regulatory strategy for proposed CMC filings.
- Monitor and assess impact of global regulations, guidance's and current regulatory environment and apply to job.
- Develop and maintain templates for IE regional requirements.
- Document CMC submissions and other communications in IMR.
- Licensing support, may represent regulatory at due diligence meetings.
- Extensive hands on experience within the pharmaceutical or biotechnology industries.
- Strong knowledge of regulatory affairs.
- CMC specific regulatory knowledge and experience.
- Direct experience with Emerging Market applications.
- Creation of regional regulatory strategies.
- Attention to detail.
- Time and project management skills.
- Problem solving.
- Strong written and verbal skills.
For more information, or to apply for this Regulatory Affairs Manager job, please contact Meera Pattni at CK Clinical on +44 (0)1438 743047 or email email@example.com.