Regulatory Affairs Consultant

Job Summary

To support a growing biotech company, the part-time Regulatory Affairs Consultant will advise on global regulatory strategy and lead IND submissions while collaborating closely with internal teams and external regulatory agencies in a flexible remote or hybrid environment.

Key Responsibilities:

• Advise on regulatory strategy and program priorities across the development portfolio
• Lead planning and preparation of IND submissions, including authoring and coordinating necessary sections
• Plan and prepare for interactions with regulatory agencies, including formal meetings and briefing documents

Required Qualifications:

• Advanced degree (PhD, PharmD, MS, or equivalent) in a scientific or medical field with 12+ years of relevant industry experience in regulatory affairs
• Proven track record of leading successful IND submissions for novel therapeutics
• Experience with regulatory strategy for biologics, particularly antibody programs
• Direct experience planning and leading interactions with the FDA and knowledge of international regulatory agencies
• Strong knowledge of FDA and ICH regulations governing biologics development