Job Description
Job DescriptionJob Overview
Our client in Boston MA is a biotechnology company that is looking a Regulatory Affairs Manager/Senior Manager. This is a fantastic opportunity to help drive innovative therapeutic solutions through the regulatory environment.
Main Functions.
- Lead and manage regulatory submissions including INDs, NDAs, BLAs, annual reports to FDA, and other health authorities globally (major markets).
- Create and implement regulatory plans to assist with clinical and commercial ventures.
- Act as main regulatory contact with FDA and other health authorities.
- Create and assess regulatory papers like briefing packages, meeting documents, and responses to agency inquiries.
- Offer regulatory guidance to cross-functional teams such as R&D, Clinical Operations, CMC, and Quality.
- Keep an eye on regulators’ evolving requirements and guidances and facilitate compliance.
- Oversee regulatory investigations for possible business development opportunities.
- Guide junior regulatory personnel and assist in developing departmental capacities.
Minimum Qualifications.
- An advanced degree (MS, PhD or PharmD) is optimal, bachelor in life sciences (or related) required.
- Must have at least five years of regulatory affairs experience in biotechnology or pharmaceutical company.
- In-depth knowledge of FDA regulations (21 CFR) and ICH guidelines
- They have demonstrated success in regulatory submissions and communicating with health authorities.
- Familiarity with biologics, small molecules, or gene/cell therapies.
- Proficient in oral and written communication
- Great project management and organizational skills.
- Capability to work smart in a quick-moving environment.
Job specification preferred qualifications
- RAC certification refers to a certification in regulatory affairs.
- Familiarity with orphan drug and breakthrough therapy designation processes.
- World regulatory expertise (EMA, Health Canada, PMDA).
- Expertise in product development for clinical and commercial stages.