Executive Director, Regulatory Science
Orchard Therapeutics
Salary
💰 $147,000 - $212,333 per year
Job Level
Mid-LevelSenior
About the role
- Enable the Global Regulatory Lead (GRL) by providing quality regulatory input and position to internal business partners including clinical development teams, commercial and GRT for assigned projects.
- Contribute to the GRT for assigned projects in alignment with the team's one regulatory voice, providing strategic input on the Target Product Profile (TPP), business planning, governance and committees; may lead GRT meetings.
- Contribute to the development of the Global Regulatory Project Strategy (GRPS) and ensure alignment with core product labeling for products in development and lifecycle management.
- May serve as a regional/local regulatory lead and point of contact with Health Authorities (HAs) for projects/products as needed.
- Accountable for developing HA engagement and interaction plans, authoring briefing documents focused on strategy and scientific content, leading meeting preparations and moderating meetings; may lead HA meetings.
- Lead submission team or regulatory sub-team to ensure NDA/BLA/MAA/Extensions filings meet project timelines and develop/update the core global dossier; collaborate with regional leads for region-specific submissions.
- Lead IND/CTA submission strategy to meet timelines for clinical trial initiation.
- Support operational and compliance activities for assigned deliverables; develop and execute regulatory submission planning activities including generating submission content plans, submission tracking, and document management utilizing cross-functional teams and alliance partners where relevant.
Requirements
- BS/BA degree in a relevant scientific discipline required.
- Advanced degree (PharmD, PhD, MD, DVM or MSc in Biology, Life Science, or related field) preferred.
- At least 6 years of relevant pharmaceutical/biotechnology experience (minimum).
- At least 4 years of relevant Regulatory Affairs experience (regional and global).
- Experience in early and late stage development of multiple modalities.
- Demonstrated experience with preparation of (s)BLA/(s)NDA/MAA, INDs/CTAs, HA meeting briefing documents and negotiating with a national/regional HA preferred.
- Experience on multidisciplinary matrixed project teams (e.g. clinical study team) preferred.
- Project leadership experience preferred.
- Note: experience within regulatory CMC not directly applicable.
- Must be US and Puerto Rico Residents Only (work authorization/residency requirement).
