Orchard Therapeutics (201-500 Employees, 7% 2 Yr Employee Growth Rate)
Location: US East Coast, UK or European Union (Remote)
Reporting to: VP, Regulatory CMC
Orchard Therapeutics is a global biotechnology company dedicated to bringing transformative cell and gene therapies to patients with serious and life-threatening orphan diseases. At Orchard, the Regulatory CMC department provides Chemistry, Manufacturing and Controls (CMC)-related regulatory expertise for development and commercial stage cell and gene therapy products, develops strategies and partners with key stakeholders to execute on the strategies in alignment with business priorities.
Key Elements and Responsibilities
- Provide Regulatory CMC leadership to Orchard Technical Operations and CMC teams in line with US, European, ICH, and other applicable regulatory requirements.
- Participate in definition and implementation of (CMC regulatory strategy for assigned program(s).
- Regularly assess information (CMC) gaps and communicate regulatory risks and related mitigation measures associated with assigned program(s) to Orchard senior management and program team(s).
- Plan, author, review and submit high quality CMC modules of investigational and marketing authorization filings for Orchard’s gene therapy products to major regulatory jurisdictions such as US, EU and UK, in collaboration with partners from Technical Operations/CMC.
- In collaboration with Technical Operations subject matter experts, prepare responses to questions and requests for information from regulatory authorities.
- Regularly review and provide regulatory assessment of change controls.
- Utilize electronic systems such as Veeva for dossier creation and tracking for CMC sections of regulatory filings.
- Monitor, analyze, and disseminate intelligence on regulatory CMC topics that may impact regulatory status of ongoing development programs or approved commercial products.
- Collaborate with global Regulatory CMC and Regulatory Science colleagues on assigned programs, and on other non-program activities related to successful implementation of department vision and goals.
Other activities as may be assigned.
- Significant (8 -10 years) regulatory CMC program leadership experience with biologics and/or Advanced Therapy Medicinal Products (ATMPs), gene therapies is a plus.
- Successful experience in independently leading Module 3 sections for investigational and marketing applications for biotech/ATMP products. US BLA experience highly preferred, including experience is preparation of modules, leading adjudications of comments, responding to FDA BLA review Information Request and any associated regulatory program management.
- Experience with life cycle management of biologics or ATMPs required.
- In-depth understanding of manufacturing, testing and regulation of biotechnology and/or gene therapy products for human use required.
- Successful experience authoring CMC documents, leading health authority oral/written communications and leading CMC-focused meetings is a must.
Skills & Abilities
- Ability to maintain high standards of professionalism and quality of work, including strategic regulatory planning and regulatory program management
- Excellent oral/written communication.
- Ability to prioritize and respond effectively to program changes.
- Ability to work in a cross-functional team environment and with remote teams.
- Strong attention to detail and the ability to handle multiple tasks in parallel.
- Excellent organizational, computer and documentation skills.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
- M.S./M.Sc or PhD in chemistry, cell biology, molecular biology, pharmacology, pharmacy, bio/chemical engineering or closely related field.
Orchard Therapeutics is an Equal Opportunity employer.