Director Regulatory Affairs, CMC - Innovative Gene Therapy Start Up
Location: Menlo Park (US)
Reporting to: Sr VP, Quality Assurance and Regulatory Affairs
Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. We are in an exciting start-up phase where a Regulatory Affairs professional can have a real impact on the strategy and foundations of what we are working to create. This role will report to the Sr VP Regulatory Affairs & QA, located in Menlo Park, CA (US) and will be a key asset in the filing for exciting ex-vivo Gene Therapy Products. This opportunity is unique due to the size of the team and the ground breaking science.
Under the guidance of the Sr VP QA and RA, the successful candidate will :
- Serve as in-house CMC regulatory contact to internal parties and regulatory bodies
- Participate in definition and implement CMC regulatory strategy for path to approval
- Plan, prepare, and review submissions, incl. CMC/quality sections to regulatory authorities (including FDA, EMA and other national authorities) to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA)
- Lead CMC regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
- Work 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.
- Understand the development, formulation and testing processes of the different Orchard’s products and provide 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
- Be 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.
- Facilitate good communication and transparency of CMC regulatory information to relevant functions
- Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
- Coordinate and prepare responses to questions, requests for information from regulatory authorities
- Monitor, analyze, and disseminate intelligence on CMC regulatory matters that may affect ongoing development programs or approved products
- Line manage, train and mentor other CMC regulatory science personnel
- Other activities as may be assigned
- 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 in a cross-functional team environment with experience managing people and project teams; ability to work with remove team
- Strong attention to detail and the ability to handle multiple tasks
- Excellent organizational, computer and documentation skills and an ability to prioritize effectively
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment and to interact efficiently with Authorities
- Regulatory Affairs Certification would be a plus
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plans. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k). Orchard Therapeutics is an equal opportunity employer.