🕒 2 days ago
Build and lead Checkout.com’s Regulatory Affairs function, managing supervisory relationships and regulatory requests while coordinating inspections, setting engagement protocols, and developing a specialist team across major markets.
Associate Director, Regulatory Strategy
📅 Sep 10
Regulatory StrategyRegulatory AffairsDrug DevelopmentRegulatory Agency Engagement
📜 Description
- Define regulatory strategy and plans for assigned programs, including anti-myostatin therapy and a new indication for an approved product.
- Represent regulatory affairs on cross-functional teams and provide strategic and operational guidance.
- Develop regulatory roadmaps and agency engagement plans with key stakeholders.
- Lead interactions with regulatory authorities and manage preparation and submission of regulatory documents, including INDs, briefing documents, DSURs, and BLAs.
- Gather and communicate regulatory intelligence, conduct research, and identify risks and opportunities with mitigation plans.
- Manage ClinicalTrials.gov disclosures and provide regulatory support for SOPs, business development, clinical labeling, and disclosure activities.
🛠️ Requirements
- Education in life sciences required
- Located in the greater Boston area required
- 5+ years of experience in biopharmaceutical industry with broad experience in regulatory affairs and drug development
- Demonstrated experience of leading successful engagement with key regulatory agencies (
- Expertise and experience with biologics (particularly monoclonal antibody therapeutics) and rare diseases strongly preferred but not required
- Demonstrated reputation as a well-respected, dynamic team leader with strong leadership and people management skills
- Strong written, verbal communication skills, and interpersonal skills
- Capable of managing shifting priorities in a rapidly changing and environment
- Ability to travel domestically and internationally (~10%)
Full job description
Scholar Rock is delivering muscle-targeted breakthroughs to transform the treatment of spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a critical unmet need.
As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more about our neuromuscular franchise at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
Summary of Position:
The Associate Director, Regulatory Strategy, is responsible for the development and implementation of regulatory strategy and plan for assigned clinical and/or pipeline programs. As a subject matter expert, this individual will represent regulatory affairs at the appropriate program team, highlighting risks and opportunities to inform program strategy and plan. The successful candidate will lead interactions with the regulatory authorities, directing the preparation and submission of regulatory submissions and correspondence to the appropriate regulatory agencies.
Position Responsibilities
Candidate Requirements
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