Regulatory Affairs Manager

2 weeks ago

London, United Kingdom Allen Recruitment Consulting Full time

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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Please don't hesitate to contact any of our team with any questions you may have on Email: info@allenrec.com

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