Director, Regulatory Affairs Advertising, Labeling, and Promotion

Beam Therapeutics • Cambridge, MA

80d

About The Position

Beam is seeking a Director of Regulatory Affairs – Advertising, Labeling, and Promotion to progress advanced genetic medicines in a fast paced and dynamic biotech environment. The person will be responsible for leading all regulatory labeling activities for Beam’s hematology programs including creation of documents (e.g. CDS, USPI) and processes.

Requirements

• BS required, an advanced degree (i.e. MS, PharmD, PhD, MD) is a plus.
• A minimum of 6 years of experience working in Regulatory Affairs Advertising, Labeling, and Promotion; ideally 15 plus years in the biotech industry with at least 8 years in regulatory affairs.
• Record of success with interactions with Regulatory Agencies and Health Authorities as part of label negotiations and label updates.
• Comprehensive knowledge of US and global regulatory procedures and practices.
• Extensive experience with regulatory documents and filings (IND, CTA/IMPD, BLA, MAA, PIP).
• Strong strategic thinking and problem-solving skills.
• Experience in representing programs to internal and external stakeholders.
• Ability to develop collaborative working relationships internally as well as externally with physicians, expert consultants, and contracted vendors.
• Excellent written/verbal communication skills, attention to detail, organizational skills.
• Demonstrated ability to mentor and manage.

Responsibilities

• Lead the creation, review, and approval of critical regulatory labeling documents including Core Data Sheet and Regional Labels for Beam hematology programs in alignment with Target Product Profiles.
• Lead labeling negotiations between Beam and health authorities as part of marketing authorization applications.
• Create regulatory labeling processes and associated SOPs, Work Instructions, and any other required documentation.
• Represent Regulatory Affairs as part of the Promotional Review Process.
• Incorporate the evolving global regulatory requirements and guidances with respect to gene editing and gene therapy, rare disease, and prescription drug labeling.
• Provide innovative regulatory approaches, solutions and guidance to cross-functional teams while mitigating regulatory risks.
• Guide and assist on the planning, preparation, writing and submission of regulatory documentation.
• Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time.
• Provide regulatory due diligence as required.
• Supervise and mentor direct reports.

What This Job Offers

• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 501-1,000 employees