Regulatory Affairs Manager, CMC. Innovative Gene Therapy Start up
The CMC Regulatory Affairs (RA) Manager will be reporting to the CMC Regulatory Affairs Director (and in interim to Sr VP CMC RA and QA, located in Menlo Park, CA (US)). This role will be located in the company headquarter in London (UK). This is a great opportunity for an industry experienced CMC RA Manager to work in a small team where he/she can make an impact.
- Writing regulatory documents incl. CMC/quality sections of global marketing authorisation applications as per agreed timelines
- Under the direction of the CMC RA Director, serving as in-house CMC regulatory contact to internal parties (and if needed to regulatory bodies)
- Working closely with CMC functional groups (mainly located in San Francisco Area - US), contract manufacturing Organisations 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’s 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
- Other activities as may be assigned
- Will report to CMC RA Director (note : in 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
- Strong 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
All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.