Sr. Director, Regulatory Strategy

Scholarrock; Cambridge (MA); On-site; USD 130,000 - 160,000; Full time

Job summary

Scholarrock in Cambridge, MA is seeking a Director or Senior Director of Regulatory Strategy to lead the global regulatory strategy for clinical and pipeline programs. The successful candidate will oversee regulatory submissions, manage relationships with regulatory authorities, and ensure compliance with applicable regulations.

The role requires a strong educational background in life sciences, along with 7+ years of experience in regulatory affairs within the biopharmaceutical industry. Leadership and communication skills are essential for this position.

Qualifications

• 7+ years of experience in Regulatory Affairs in the biopharmaceutical industry.
• Expertise and experience with biologics, particularly monoclonal antibody therapeutics preferred.
• Strong ability to manage shifting priorities in a fast-paced environment.

Responsibilities

• Develop and implement global regulatory strategy and plan.
• Lead interactions with regulatory authorities and prepare submissions.
• Monitor regulatory landscape and ensure compliance.

Skills

Regulatory Strategy

Leadership

Communication Skills

Interpersonal Skills

Education

Education in Life Sciences

Job description

Summary of Position

The Director or Senior Director, Regulatory Strategy, reporting to the SVP, Global Head of Regulatory Affairs, is responsible for the development and implementation of the Global Strategy for assigned clinical and/or pipeline programs globally depending on the program. 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.

Responsibilities & Qualifications

• 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
• 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%)

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.