Senior Manager, Regulatory Affairs

Beam is seeking a Sr Manager/Manager Regulatory Affairs to progress a broad portfolio of advanced genetic medicines in a fast-paced and dynamic biotech environment.

Requirements

• BS in a medical or scientific field required, an advanced degree (i.e. MS, PharmD, PhD, MD) is a plus.
• Strong grasp of drug development lifecycle and strategy.
• A minimum of 5 years of experience working in Regulatory Affairs; additional experience in other fields of the biotech industry is a plus; experience with advanced therapies a plus.
• Knowledge of US and global regulatory procedures and practices.
• Firsthand experience with regulatory document authoring and submission (e.g. IND, CTA, BLA, MAA, PIP).
• Experience supporting teams through interactions with Regulatory Agencies and Health Authorities.
• Ability to develop and maintain collaborative working relationships with internal and external partners.
• Excellent written/verbal communication skills, attention to detail, organizational skills.

Benefits

• Health insurance
• Retirement plan
• Stock options