Director/Sr. Director, Regulatory Strategy

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental.

Requirements

• Education in life sciences required
• 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
• 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

• Equal Opportunity Employer
• Commitment to creating an inclusive environment for all employees