Company Overview:
Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
Position Overview:
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. The person will be responsible for supporting the development and implementation of the global regulatory strategy for Beam’s programs.
Responsibilities:
- In partnership and under guidance from the Regulatory Lead, drive the development of global regulatory strategy for Beam’s portfolio of advanced genetic medicines and ensure integration of regulatory tactics that support the broader corporate strategy.
- Incorporate evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, orphan indications, breakthrough treatments and other relevant regulations.
- Maintain and update regulatory submission plans, timelines, and other core strategic documents.
- As needed, represent Regulatory Affairs on cross functional and project teams to ensure regulatory input into non-clinical, clinical and commercial strategies.
- 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.
- Other activities as needed.
Qualifications:
- 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.
The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.
Top Skills
Beam Therapeutics Cambridge, Massachusetts, USA Office
238 Main ST, Cambridge, Massachusetts , United States, 02142
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