Associate Director, CMC Regulatory Science - RCMC3
London, England, United Kingdom
Location: London (UK)
Reporting to: Chief of Regulatory Science
The Associate Director, CMC Regulatory Science will be reporting to the Chief of Regulatory Science (and in interim to Sr VP CMC RS and QA, located in Menlo Park, CA (US)). This role will be located in the company headquarter in London (UK). A great opportunity for an industry experienced Associate Director, CMC Regulatory Science to work in a small team where he/she can make an impact. Also, an ideal position for a qualified CMC Regulatory professional to take the next step in their career within a fast-growing biotech organisation that already has a global footprint.
- Developing scientific and regulatory briefing documents for pre-IND, end of phase II, and pre-BLA and MAA meetings with regulatory agencies.
- Writing regulatory documents incl. CMC/quality sections of global marketing authorisation applications as per agreed timelines.
- Under the direction of the Chief of Regulatory Science, serving as in-house CMC regulatory contact to internal parties.
- Interaction with regulatory agencies to negotiate and navigate the regulatory requirements.
- Working closely with CMC functional groups (mainly located in San Francisco Area - US), contract manufacturing organisations (CMOs) and other Regulatory Colleagues to plan and produce high quality regulatory submissions while meeting aggressive timelines.
- Understanding the development, formulation and testing processes of the different Orchard products assigned to him/her and providing relevant regulatory guidance and advice in a timely manner to expedite the manufacturing process and necessary tech transfers while ensuring conditions for meeting regulatory requirements are maintained.
- Being responsible for maintaining up to date knowledge of CMC regulatory requirements and communicate changes in regulatory information to project teams and senior management in a timely manner.
- Facilitating good communication and transparency of CMC regulatory information to relevant functions.
- Vast experience in the biotech industry and proven experience in CMC regulatory supporting new biologic products.
- Strong working knowledge and understanding of biologics is highly desired to be considered at AD level.
- Will report to the Chief of Regulatory Science (Note : In the interim, he/she will report to Sr VP, CMC RA & QA)
- M.S. or PhD in chemistry, cell biology, pharmacology, pharmacy or closely related field
- Extensive regulatory affairs industry experience
- Significant CMC regulatory experience with demonstrable knowledge of the manufacturing and regulation of biotechnology and gene therapy products for human use
- Successful experience writing CMC documents that comply with regulatory requirements
- Ability to maintain high standards of professionalism, quality, and prioritization
- Ability to work with remote teams
- Regulatory Affairs Certification would be a plus