Associate Director, Regulatory Strategy
Solid Biosciences, Boston, MA, United States
Associate Director, Regulatory Strategy – Solid Biosciences
Location: Charlestown, MA – Hybrid (2–3 days in office at Hood Park headquarters).
We are seeking an Associate Director, Regulatory Strategy, to advance and execute end-to-end regulatory strategies that enable efficient program progression across all stages of development. Reporting to the Director, Regulatory Strategy, the candidate will support Solid’s regulatory strategy and process, playing an active role in agency interactions, applications, and driving innovative regulatory pathways to support gene therapy development. A motivated and agile regulatory professional who is keen to be part of a collaborative team with a goal to develop global regulatory experience in gene therapy drug development will thrive in this role.
Key Position Responsibilities
Serve as an active representative of Regulatory on interdisciplinary teams internally (Clinical Study Teams, Program Teams, etc.) and with external partners (CROs, consultants).
Drive the development and implementation of regulatory strategies to facilitate the progress of programs through all phases of development.
Collaborate with cross‑functional teams to generate and refine the product development strategy and identify potential regulatory risks.
Lead global clinical trial applications including the preparation of initial INDs/CTAs/GMOs and amendments, responses to agency questions, and maintenance activities.
Drive regulatory submissions, including necessary cross‑functional teams and timelines, relevant to assigned projects or programs.
Actively contribute to the preparation and execution of agency meetings.
Support development and implementation of global regulatory strategies, including identifying regulatory risks, to facilitate the progress of programs through all phases of development.
Actively monitor regulatory policy and intelligence and disseminate information to inform program strategy.
Act as resource for team on evolving regulatory requirements, regulatory precedents, and intelligence.
Actively monitor regulatory policy and intelligence and disseminate information to teams.
Experience Requirements
PharmD or PhD preferred. Minimum of 6 years of experience in regulatory affairs in the biotech/pharma industry, including IND activity, global CTAs, DSURs, and agency briefing documents in US and ex‑US.
Strong preference for candidates with prior small biotech experience.
Strong knowledge of US regulations and guidances pertaining to the conduct of investigational drug studies; ex‑US experience highly desirable.
Experience in gene therapy and/or rare disease programs a plus, although not required.
Self‑starter mentality, with the ability to independently and effectively organize and prioritize tasks to achieve established deadlines.
Ability to work both independently and collaboratively within project teams, committees, etc. to achieve group goals.
Excellent verbal and written communication skills.
Excellent organizational and program management skills that ensure timely completion of objectives by appropriate prioritization, scheduling and assignment of tasks.
Creative problem solving and strategizing abilities.
Compensation The base compensation range for this role is: $170,000.00 - $220,000.00
Benefits And Solid Advantages
Competitive Health and Dental programs with flexible plan offerings, including FSA and HSA programs
401(k) program participation with competitive company matched contributions
Eligibility to participate in Solid’s Employee Stock Purchase Plan
Mobile phone subsidy for eligible employees
Tuition Reimbursement
Vision Coverage
Life Insurance
Voluntary Pet Insurance
Employee Discount Program on Travel, Entertainment, and Services
Employee Assistance Programs
Daily Subsidized Lunch Delivery (onsite @ Hood Park)
Free Onsite Full‑Service Gym (onsite @ Hood Park)
Employee Parking (onsite @ Hood Park)
12 Observed Holidays and a winter shut down
15‑day PTO Policy and a 40‑hour rollover YoY
40‑hour Sick Policy
8‑Hour Floating Holiday
#J-18808-Ljbffr
We are seeking an Associate Director, Regulatory Strategy, to advance and execute end-to-end regulatory strategies that enable efficient program progression across all stages of development. Reporting to the Director, Regulatory Strategy, the candidate will support Solid’s regulatory strategy and process, playing an active role in agency interactions, applications, and driving innovative regulatory pathways to support gene therapy development. A motivated and agile regulatory professional who is keen to be part of a collaborative team with a goal to develop global regulatory experience in gene therapy drug development will thrive in this role.
Key Position Responsibilities
Serve as an active representative of Regulatory on interdisciplinary teams internally (Clinical Study Teams, Program Teams, etc.) and with external partners (CROs, consultants).
Drive the development and implementation of regulatory strategies to facilitate the progress of programs through all phases of development.
Collaborate with cross‑functional teams to generate and refine the product development strategy and identify potential regulatory risks.
Lead global clinical trial applications including the preparation of initial INDs/CTAs/GMOs and amendments, responses to agency questions, and maintenance activities.
Drive regulatory submissions, including necessary cross‑functional teams and timelines, relevant to assigned projects or programs.
Actively contribute to the preparation and execution of agency meetings.
Support development and implementation of global regulatory strategies, including identifying regulatory risks, to facilitate the progress of programs through all phases of development.
Actively monitor regulatory policy and intelligence and disseminate information to inform program strategy.
Act as resource for team on evolving regulatory requirements, regulatory precedents, and intelligence.
Actively monitor regulatory policy and intelligence and disseminate information to teams.
Experience Requirements
PharmD or PhD preferred. Minimum of 6 years of experience in regulatory affairs in the biotech/pharma industry, including IND activity, global CTAs, DSURs, and agency briefing documents in US and ex‑US.
Strong preference for candidates with prior small biotech experience.
Strong knowledge of US regulations and guidances pertaining to the conduct of investigational drug studies; ex‑US experience highly desirable.
Experience in gene therapy and/or rare disease programs a plus, although not required.
Self‑starter mentality, with the ability to independently and effectively organize and prioritize tasks to achieve established deadlines.
Ability to work both independently and collaboratively within project teams, committees, etc. to achieve group goals.
Excellent verbal and written communication skills.
Excellent organizational and program management skills that ensure timely completion of objectives by appropriate prioritization, scheduling and assignment of tasks.
Creative problem solving and strategizing abilities.
Compensation The base compensation range for this role is: $170,000.00 - $220,000.00
Benefits And Solid Advantages
Competitive Health and Dental programs with flexible plan offerings, including FSA and HSA programs
401(k) program participation with competitive company matched contributions
Eligibility to participate in Solid’s Employee Stock Purchase Plan
Mobile phone subsidy for eligible employees
Tuition Reimbursement
Vision Coverage
Life Insurance
Voluntary Pet Insurance
Employee Discount Program on Travel, Entertainment, and Services
Employee Assistance Programs
Daily Subsidized Lunch Delivery (onsite @ Hood Park)
Free Onsite Full‑Service Gym (onsite @ Hood Park)
Employee Parking (onsite @ Hood Park)
12 Observed Holidays and a winter shut down
15‑day PTO Policy and a 40‑hour rollover YoY
40‑hour Sick Policy
8‑Hour Floating Holiday
#J-18808-Ljbffr