Scholar Rock

Director/Sr. Director, Regulatory Strategy

Scholar Rock

full-time

Posted on:

Location Type: Hybrid

Location: Cambridge • Massachusetts • United States

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Salary

💰 $200,000 - $300,000 per year

Job Level

Senior

About the role

  • Serve as a thought leader on regulatory affairs, defining global regulatory strategy and plan to maximize regulatory success.
  • Serve as the global regulatory lead, providing strategic and operational input on assigned clinical and/or pipeline programs, such as the subcutaneous (IV to SC) and OPAL (<2 years old) program teams to achieve program objectives while ensuring compliance with applicable regulatory requirements in the region.
  • Be responsible for leading the global supplemental/type 2 variation filing lead for OPAL (<2 years old)
  • Develop regulatory roadmap to inform and guide agency engagement strategy; partner with key stakeholders to develop and implement a comprehensive regulatory engagement plan
  • Lead and managing regulatory interactions on assigned programs, building trusted relationships with regulatory authorities
  • Lead cross-functional effort to ensure timely submission of key regulatory documents (e.g., Module 1, briefing documents)
  • Ensure program team members and cross-functional stakeholders are informed of internal and external events that may impact regulatory success
  • Identify regulatory risks and opportunities and work with key stakeholders to develop solutions
  • Partner with global market access and medical affairs colleagues to support interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable
  • Partner with Global and local Marketing/ Commercial as needed to align Regulatory Plan and Marketing/Commercial plan
  • Ensure strong representation of regulatory voice at key governance bodies and teams (e.g., DRC, program teams, clinical development teams, study teams)
  • Maintain currency of regulatory requirements and approvals to inform regulatory strategies and drive proactive plans to ensure compliance
  • Monitor and analyze global and country specific regulatory landscape to assess potential impact on the program; collaborate with teams to ensure compliance
  • Provide support to local regulatory experts
  • Provide regulatory support for cross-functional activities (e.g., SOPs, business development, clinical labeling, disclosure) as needed

Requirements

  • Education in life sciences required
  • Greater Boston-based with ability to be regularly present in the Cambridge, MA office
  • 7+ years of experience Regulatory Affairs in biopharmaceutical industry with deep understanding of EU regulatory requirements
  • Demonstrated experience of leading successful engagement with EMA
  • 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%)
Benefits
  • Scholar Rock is an Equal Opportunity Employer.
  • We celebrate diversity and are committed to creating an inclusive environment for all employees.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategyregulatory complianceregulatory roadmapregulatory submissionsregulatory documentsregulatory risk assessmentbiologicsmonoclonal antibodiesclinical labelingSOPs
Soft Skills
leadershippeople managementcommunicationinterpersonal skillsstrategic thinkingrelationship buildingproblem solvingadaptabilityteam collaborationstakeholder engagement