Associate Director, Regulatory Sciences CMC - Menlo Park
Menlo Park, California, United States
Location: Menlo Park (US)
Reporting to: VP Regulatory CMC
Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Created three years ago, it is in an exciting start-up phase where a Regulatory Affairs professional can have a real impact on the work and foundations that are being created. This role will report to the VP Regulatory CMC, 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 VP Regulatory CMC, the successful candidate will:
- Serve as an in-house regulatory CMC contact to internal partners, external partners, and external regulatory authorities
- Participate in the development and implementation of regulatory CMC strategy to facilitate the path to regulatory application approvals
- Plan, prepare, and review submissions, including 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, IMPD, BLA, MAA)
- Lead regulatory CMC activities for assigned projects meeting US FDA, EU EMA, and other national authority requirements as well as ensuring compliance with cGMPs and other international standards
- 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 ambitious timelines
- With an understanding in the science and technologies involved in the development, manufacturing, and testing of the different Orchard products, provide relevant regulatory guidance and advice to facilitate product development, manufacturing, and technology transfer activities in support of Orchard clinical development and commercial product programs
- Be responsible for maintaining up to date knowledge of regulatory CMC requirements and communicate changes in regulatory information to project teams and senior management
- Monitor, analyze, and disseminate intelligence on regulatory CMC matters that may affect ongoing development programs or approved products
- Line manage, train and mentor other regulatory CMC personnel
- Bachelor’s degree or higher in science, engineering, or equivalent experience
- Significant (10 or more years) regulatory CMC experience with demonstrable knowledge of the manufacturing and regulation of biotechnology, cell therapy, and gene therapy products for human use
- Successful experience writing CMC documents that comply with regulatory requirements
- Ability to work in a cross-functional team environment with experience managing people and project teams; ability to work with remote teams
- Strong attention to quality, detail, and the ability to handle multiple tasks
- Excellent organizational, computer and documentation skills and an ability to prioritize effectively
- Strong professional and interpersonal skills including verbal and written communication are essential in this collaborative work environment
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.
Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
For further information on this role do not hesitate to email HR@orchard-tx.com
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.