Are you an experienced Regulatory Affairs professional with a background in Chemistry, Manufacturing and Controls and experience working in the Biopharmaceutical/Biotechnology industry, and are you looking for a new opportunity? We have your next role, we are recruiting for a Regulatory Affairs CMC Manager with Post Approval Submissions and who has liaised with Global Regulatory bodies.
To be considered for this role you must have a background in Chemistry, Manufacturing and Controls Regulatory Affairs within the Pharma/BioPharma space.
Job Title: Regulatory Affairs CMC Manager
Location: Central London
Contract Type: Outside IR35 (Hybrid role)
Duration: 12 months
Job Reference: BBBH 23997
About the role
We are looking for an experienced Regulatory Affairs CMC Manager to join our client in Central London. The ideal candidate will have a strong understanding of regulatory requirements for biopharmaceuticals and will be able to work independently and as part of a team to support global commercial post-approval submissions.
Responsibilities:
- Represent the regulatory CMC department at meetings with both internal and external stakeholders, provide feedback on site initiatives, and ensure that all regulatory requirements are met.
- Compile and manage all documentation required for commercial regulatory CMC submissions, in a timely manner. Respond to questions from other departments and regulatory authorities.
- Liaise with teams in the United States, United Kingdom, and European Union to prepare change controls and GMP documentation for global submissions of product registrations and/or renewals.
- Participate in cross-functional project teams as a representative of the regulatory CMC department, and contribute to discussions on project-specific topics.
- Proactively identify potential issues and suggest strategies to mitigate risks.
- Assist in the preparation for interactions with global regulatory authorities, such as the FDA, MHRA, and EMA.
Minimum requirements:
- A background working within the Bio Pharma Space
- 5+ years of regulatory affairs CMC experience
- Site and global regulatory CMC experience
- Use of Software/tools such as Veeva vault
- Experience in the biopharmaceutical/biotechnology industry
Still interested in this opportunity?
Submit your CV (in a Microsoft Word format) today!
OR
Perhaps this role didn’t fully fit your criteria, not to worry – we have many similar roles advertised on our website – www.allenrec.com
Please don’t hesitate to contact any of our team with any questions you may have on Email: [email protected]
