Regulatory Affairs Manager​/Sr Manager

Job 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 Pharm
  
  D) 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.

Regulatory Affairs Manager Sr Manager
• Boston, MA, US