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Head of RA CMC
- Posted 13 January 2023
- LocationCambridge
- Job type Contract
- Reference77001
- Contact NameDavid Skinner
Job description
Head of RA CMC
The Head of CMC Regulatory Affairs will be responsible for developing and implementing innovative, breakthrough CMC strategies, from discovery support to product development and approval for projects. Serving as the Regulatory Affairs expert, you will ensure adherence to relevant regulatory requirements, representing the company with domestic and international regulatory authorities, contractors and corporate partners as needed.
Key responsibilities:
What we are looking for:
The Head of CMC Regulatory Affairs will be responsible for developing and implementing innovative, breakthrough CMC strategies, from discovery support to product development and approval for projects. Serving as the Regulatory Affairs expert, you will ensure adherence to relevant regulatory requirements, representing the company with domestic and international regulatory authorities, contractors and corporate partners as needed.
Key responsibilities:
- Manage the preparation, drafting, review, risk analysis and mitigation planning of submissions for projects
- Collaborate with external regulatory bodies, to support the execution of regulatory submissions, audits and inspections
- Develop and maintain internal cross-functional relationships to support the development and execution of regulatory strategy
- Spearhead compliance activities of the company’s portfolio to determine regulatory impact and submission requirement for regulatory filings in accordance with specific countries
- Provide support and advice for internal and external customers in line with defined regulatory plans and respond to ad-hoc questions in a timely manner
- Maintain working knowledge of relevant laws, guidance and requirements
- Analyse trends and evaluates the impact of changes in Regulatory requirements for CMC related submissions, communicating changes to appropriate areas to ensure compliance with required standards
- Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to the client’s products
What we are looking for:
- Bachelor’s degree in a life science related discipline
- 8+ years relevant experience in regulatory affairs in pharma or biotech, specifically CMC
- Experience in regulatory affairs strategy development, management and execution
- Comprehensive understanding of pharmaceutical development, manufacturing processes, GMP and the regulatory environment
- Understanding of requirements for safe scale-up of biochemical processes
- Demonstrable ability to build relationships and work collaboratively with cross functional teams
- An excellent project manager with ability to multitask
- Excellent communication and interpersonal skills
- Must hold right to work in the UK