Associate Director, Regulatory Strategy
Solid Biosciences
June 25, 2026
Remote friendly (Boston, MA)
United States
$170,000 - $220,000 USD yearly
Corporate Functions
Key Position Responsibilities:
- Represent Regulatory on interdisciplinary teams and with external partners (CROs, consultants).
- Develop and implement end-to-end regulatory strategies to advance programs through all development phases.
- Collaborate cross-functionally to refine product development strategy and identify regulatory risks.
- Lead global clinical trial applications: prepare initial INDs/CTAs/GMOs and amendments; respond to agency questions; manage maintenance.
- Drive regulatory submissions with appropriate cross-functional timelines.
- Contribute to preparation and execution of agency meetings.
- Monitor regulatory policy/intelligence and disseminate to inform program strategy; serve as a resource on evolving requirements and regulatory precedents.
Experience Requirements / Qualifications:
- PharmD or PhD preferred.
- Minimum 6 years in regulatory affairs (biotech/pharma), including IND activity, global CTAs, DSURs, and agency briefing documents in US and ex-US.
- Strong preference: prior small biotech experience.
- Strong knowledge of US regulations/guidances for investigational drug studies; ex-US experience highly desirable.
- Experience in gene therapy and/or rare disease programs a plus.
- Self-starter; independently organize/prioritize to meet deadlines.
- Ability to work independently and collaboratively across teams.
- Excellent verbal/written communication; strong organizational/program management; creative problem solving.
Compensation:
- Base range: $170,000.00–$220,000.00.
Benefits:
- Health/dental (FSA/HSA), 401(k) match, Employee Stock Purchase Plan, mobile phone subsidy, tuition reimbursement, vision, life insurance, pet insurance, employee discount, EAP, onsite lunch, onsite gym, onsite parking, holidays/winter shut down, PTO + rollover, sick policy, floating holiday.
- Represent Regulatory on interdisciplinary teams and with external partners (CROs, consultants).
- Develop and implement end-to-end regulatory strategies to advance programs through all development phases.
- Collaborate cross-functionally to refine product development strategy and identify regulatory risks.
- Lead global clinical trial applications: prepare initial INDs/CTAs/GMOs and amendments; respond to agency questions; manage maintenance.
- Drive regulatory submissions with appropriate cross-functional timelines.
- Contribute to preparation and execution of agency meetings.
- Monitor regulatory policy/intelligence and disseminate to inform program strategy; serve as a resource on evolving requirements and regulatory precedents.
Experience Requirements / Qualifications:
- PharmD or PhD preferred.
- Minimum 6 years in regulatory affairs (biotech/pharma), including IND activity, global CTAs, DSURs, and agency briefing documents in US and ex-US.
- Strong preference: prior small biotech experience.
- Strong knowledge of US regulations/guidances for investigational drug studies; ex-US experience highly desirable.
- Experience in gene therapy and/or rare disease programs a plus.
- Self-starter; independently organize/prioritize to meet deadlines.
- Ability to work independently and collaboratively across teams.
- Excellent verbal/written communication; strong organizational/program management; creative problem solving.
Compensation:
- Base range: $170,000.00–$220,000.00.
Benefits:
- Health/dental (FSA/HSA), 401(k) match, Employee Stock Purchase Plan, mobile phone subsidy, tuition reimbursement, vision, life insurance, pet insurance, employee discount, EAP, onsite lunch, onsite gym, onsite parking, holidays/winter shut down, PTO + rollover, sick policy, floating holiday.