Regulatory Strategy Manager – Solid Biosciences
Charlestown, MA
Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy, Friedreich’s ataxia, catecholaminergic polymorphic ventricular tachycardia, TNNT2‑mediated dilated cardiomyopathy, BAG3‑mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. We are advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care.
Patient‑focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases.
We are seeking a creative and agile regulatory professional to be part of a collaborative, fast‑paced team and develop global regulatory experience in gene therapy drug development. The candidate will play an active role in agency interactions, INDs, CTAs, GMOs, PIPs, and innovative regulatory pathways that support gene therapy development.
This role will be based in Solid’s Corporate Headquarters located in Hood Park in Charlestown, MA and is a hybrid position averaging 2–3 days per week in the office.
Key Position Responsibilities
Actively represents Regulatory on interdisciplinary teams (e.g., Clinical Study Teams)
Support US, EU, and global clinical trials including the preparation of initial INDs/CTAs/GMOs and amendments, responses to agency questions, and maintenance activities.
Support development and implementation of regulatory strategies to facilitate the progress of programs through all phases of development
Offer submission strategies for development products and identify potential regulatory risks
Collaborate with cross‑functional teams to generate and refine the product development strategy
Responsible for coordinating and driving 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
Act as regulatory representative at meetings with business partners such as CROs, consultants, etc.
Act as resource for team on evolving regulatory requirements, regulatory precedents, and intelligence
Ability to work both independently and within project teams, committees, etc. to achieve group goals.
Represent Solid Bio Regulatory through participation in pharmaceutical trade groups and meetings
Actively monitor regulatory policy and intelligence and disseminate information to teams
Experience Requirements
Bachelor’s degree in a scientific discipline; Masters, PharmD, or PhD preferred. Minimum of 2 years of experience in regulatory affairs in the pharmaceutical/biotech, including IND activity, global CTAs, DSURs and Agency briefing documents in US and ex‑US.
Experience in gene therapy programs and/or rare disease a plus, although not required
Strong knowledge of US and EU regulations and Guidelines pertaining to the conduct of investigational drug studies
Key Position Attributes
Ability to effectively organize and prioritize tasks to achieve established deadlines
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
Strong collaborator with multi‑disciplinary teams
Creative problem solving and strategizing abilities
Compensation The base compensation range for this role is: $125,000 - $160,000.
Base salary offered is determined through an internal analysis utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short‑term and long‑term incentives, including cash bonus and equity incentive opportunities, designed to reward individual performance and align incentives to Solid’s long‑term company performance.
Benefits And Solid Advantages At Solid Biosciences we offer a highly competitive total rewards and benefits package, intended to support all aspects of our employees’ lives and well‑being. Additionally, for those employees working onsite at our Hood Park Headquarters, we offer a variety of onsite resources to support those working in our offices.
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 Programme on Travel, Entertainment, and Services
Employee Assistance Programs
Daily Subsidised 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
Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy, Friedreich’s ataxia, catecholaminergic polymorphic ventricular tachycardia, TNNT2‑mediated dilated cardiomyopathy, BAG3‑mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. We are advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care.
Patient‑focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases.
We are seeking a creative and agile regulatory professional to be part of a collaborative, fast‑paced team and develop global regulatory experience in gene therapy drug development. The candidate will play an active role in agency interactions, INDs, CTAs, GMOs, PIPs, and innovative regulatory pathways that support gene therapy development.
This role will be based in Solid’s Corporate Headquarters located in Hood Park in Charlestown, MA and is a hybrid position averaging 2–3 days per week in the office.
Key Position Responsibilities
Actively represents Regulatory on interdisciplinary teams (e.g., Clinical Study Teams)
Support US, EU, and global clinical trials including the preparation of initial INDs/CTAs/GMOs and amendments, responses to agency questions, and maintenance activities.
Support development and implementation of regulatory strategies to facilitate the progress of programs through all phases of development
Offer submission strategies for development products and identify potential regulatory risks
Collaborate with cross‑functional teams to generate and refine the product development strategy
Responsible for coordinating and driving 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
Act as regulatory representative at meetings with business partners such as CROs, consultants, etc.
Act as resource for team on evolving regulatory requirements, regulatory precedents, and intelligence
Ability to work both independently and within project teams, committees, etc. to achieve group goals.
Represent Solid Bio Regulatory through participation in pharmaceutical trade groups and meetings
Actively monitor regulatory policy and intelligence and disseminate information to teams
Experience Requirements
Bachelor’s degree in a scientific discipline; Masters, PharmD, or PhD preferred. Minimum of 2 years of experience in regulatory affairs in the pharmaceutical/biotech, including IND activity, global CTAs, DSURs and Agency briefing documents in US and ex‑US.
Experience in gene therapy programs and/or rare disease a plus, although not required
Strong knowledge of US and EU regulations and Guidelines pertaining to the conduct of investigational drug studies
Key Position Attributes
Ability to effectively organize and prioritize tasks to achieve established deadlines
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
Strong collaborator with multi‑disciplinary teams
Creative problem solving and strategizing abilities
Compensation The base compensation range for this role is: $125,000 - $160,000.
Base salary offered is determined through an internal analysis utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short‑term and long‑term incentives, including cash bonus and equity incentive opportunities, designed to reward individual performance and align incentives to Solid’s long‑term company performance.
Benefits And Solid Advantages At Solid Biosciences we offer a highly competitive total rewards and benefits package, intended to support all aspects of our employees’ lives and well‑being. Additionally, for those employees working onsite at our Hood Park Headquarters, we offer a variety of onsite resources to support those working in our offices.
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 Programme on Travel, Entertainment, and Services
Employee Assistance Programs
Daily Subsidised 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