My client are seeking a Senior Regulatory Affairs Associate with CMC knowledge to join their International Regulatory Affairs team. This person will work alongside the Product Leads, to support pipeline and portfolio across 45 ROW countries.
In this vital role you will be responsible for the preparation of the CMC content of Clinical Trial Applications, Marketing Applications, and Post-approval Variations dossiers that comply with International country/region regulatory standards.
You will be working within the document management system on compilation of submission documents, tracking of submissions and approvals dates, and response to question preparation.
- Responsibility for the execution of the preparation of International Clinical Trial Applications, Marketing Applications and post-market supplements/variations.
- Work with local country affiliates to act with local regulatory authorities.
- Coordinate timely submissions of CMC content to regulatory authorities according to local regulations.
- Assisting in the development of regulatory strategies for submissions, while adhering to country requirements and approval processes.
- Maintain local tracking and archival of submissions and approvals.
- Contribute comments to Regulatory guidance documents Regulatory intelligence updates, compliance gap assessments.
- Support the resolution of any problems on the critical path to the CMC dossier submission in concert with the CMC product representative or delegate, publishing and International regulatory.
- Support response to questions raised by authorities.
Key Skills Required:
- Master’s or Bachelor’s degree or equivalent
- 1-5 years Regulatory Affairs experience
- CMC specific regulatory knowledge and experience or in the manufacture/testing of pharmaceutical products
- Excellent communication skills with ability to communicate across all levels
- Strong MS Office skills.
This role will be majority work-from-home in the UK, with occasional trips to the Uxbridge or Cambridge offices required.
In return for your work, my client offer growth opportunities to learn and move up in a global organization, working in a diverse and inclusive community of belonging. They offer a generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.
If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +441293 584300, or apply with your CV to arrange a confidential discussion.
- Regulatory Affairs Senior Manager
Job location: Job salary: £750000 to £85000
My client is a large biotech company who are lo...
- R&D Lab Manager
Job location: Dublin Job salary: £40000 to £45000
My client is a clinical stage biopharmaceutical...
- Clinical Research Physician
Job location: Job salary: £60000 to £80000
Our client a leading global CRO is looking f...