The Regulatory Affairs Manager, CMC will be reporting to the Chief Regulatory Officer and will be able to have a strong input on the Regulatory CMC processes. This role will be located in the development facility in Foster City alongside the Manufacturing team. This is a great opportunity for an industry experienced Regulatory CMC Manager to work in a small team where he/she can make an impact.
• Writing regulatory documents incl. CMC/quality sections and serving as US in-house regulatory contact to internal and external parties
• Working closely with CMC functional groups (mainly located in San Francisco Area), contract manufacturing Organisations and other Regulatory Colleagues to plan and produce high quality regulatory submissions while meeting aggressive timelines.
• Overseeing the development, formulation and testing processes of the different Orchard’s products and providing relevant regulatory guidance and advice to expedite the manufacturing process and necessary tech transfers while ensuring conditions for meeting regulatory requirements are maintained
• Ensuring filings are completed in a timely manner, that consistency is maintained across development projects, and that sound scientific justification is employed in CMC regulatory strategy
• Being responsible for preparing and/or overseeing the preparation of technically complex regulatory CMC submissions which require extensive interaction with departments within CMC and Regulatory Affairs for clinical and future commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.
• Being responsible for maintaining up to date knowledge of regulatory requirements and communicate changes in regulatory information to project teams and senior management in a timely manner.
• Under the directions of the Chief Regulatory Officer, serving as a liaison between our company and regulatory bodies on CMC related topics
• Facilitating good communication and transparency of CMC information to relevant functions
• Taking a leadership position in conducting risk assessments on major global CMC regulatory issue
• Will report to Chief Regulatory Officer
• M.S. or PhD in chemistry, cell biology, pharmacology, pharmacy or closely related field
• Minimum of 5 years of regulatory affairs industry experience specific to gene therapy manufacturing
• Significant CMC experience with demonstrable knowledge of the manufacturing and regulation of biotechnology and gene therapy products for human use
• Successful experience in negotiations with regulatory bodies and experience writing CMC documents that comply with regulatory requirements
• Ability to maintain high standards of professionalism, quality, and prioritization
• Regulatory Affairs Certification would be a plus
• Localisation in Foster City area, would be a plus
Please send your resume and cover letter to HR@orchard-tx.com