Regulatory Affairs Manager

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
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