Director, Regulatory CMC
Location: East Coast, US (Remote)
Reporting to: VP, Regulatory CMC
Job summary
Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases.
Key Elements and Responsibilities
- Provide Regulatory CMC leadership to Orchard Technical Operations and Chemistry, Manufacturing and Controls (CMC) teams in line with US, European, ICH, and other applicable regulatory requirements.
- Participate in definition and implementation of Chemistry, Manufacturing and Controls (CMC) regulatory strategy for assigned program(s).
- Regularly assess and communicate regulatory risks 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, Europe 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.
- 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 to successfully implement department vision and goals.
- Other activities as may be assigned.
Requirements
Required knowledge/experience
- Significant (8 -10 years) regulatory CMC program leadership experience with biologics and/or Advanced Therapy Medicinal Products (ATMPs)
- Successful experience in independently leading Module 3 sections for investigational and marketing applications for biotech/ATMP products.
- Experience with life cycle management of biologics or ATMPs required.
- In-depth understanding of manufacturing, testing and regulation of 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 amp; Abilities
- Ability to maintain high standards of professionalism and quality of work, including strategic regulatory planning, regulatory program management and 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.
- Excellent organizational, computer and documentation skills.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
- M.S. or PhD in chemistry, cell biology, pharmacology, pharmacy, bio/chemical engineering or closely related field.
Education
- M.S. or PhD in chemistry, cell biology, pharmacology, pharmacy, bio/chemical engineering or closely related field.
Benefits
Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.
We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.