Consultant: Regulatory Affairs

About the role:

A stealth mode biotech company is looking for an experienced, part time (20 hours/week)

Regulatory Affairs Consultant to advise on the global regulatory strategy for its novel therapeutics. The consultant will give strategic and hands-on regulatory input as the company advances its programs through IND-enabling activities and into the clinic. This person will work closely with company leadership, internal teams, and the company's clinical development consultant to make sure clinical and regulatory strategies are aligned. They will also help plan and lead interactions with the FDA and other regulatory agencies.

This is a chance to shape the regulatory path of new drugs for patients at an early-stage therapeutics company backed by highly regarded investors.

Key responsibilities:

• ● Advise on regulatory strategy, program priorities, and regulatory pathways across the company's development portfolio
• ● Work closely with the clinical development consultant and internal teams to align regulatory strategy with clinical development plans, trial design, and program timelines
• ● Lead planning and preparation of IND submissions, including authoring, review, and coordination of nonclinical, clinical, and CMC (Module 3) sections
• ● Plan and prepare for interactions with regulatory agencies, including pre-IND, INTERACT, and other formal meetings, as well as briefing documents and meeting requests
• ● Participate in meetings with company leadership, regulatory authorities, clinical investigators, and external development partners, as requested
• ● Review and provide strategic regulatory input on scientific data, study reports, protocols, investigator brochures, and other development materials
• ● Advise on applicable regulatory requirements and guidance, including GLP, GCP, GMP, and
• FDA/ICH guidelines relevant to biologic therapeutics
• ● Identify regulatory risks and opportunities, including expedited development programs (e.g., Fast Track, Breakthrough Therapy, Orphan Drug designation), and recommend mitigation or pursuit strategies
• ● Advise on the selection, oversight, and engagement of regulatory vendors, publishing partners, and CROs supporting regulatory activities
• ● Support maintenance of regulatory filings after IND submission, including amendments, safety reporting requirements, and annual reports
• ● Provide additional strategic regulatory advice and subject-matter expertise as reasonably requested by the company
• ● Work closely with scientists and operators in a fast-paced biotech startup environment, operating effectively with a high degree of autonomy

Qualifications:

• ● Advanced degree (PhD, PharmD, MS, or equivalent) in a scientific, medical, or related field, with 12+ years of relevant industry experience in regulatory affairs preferred; RAC certification is a plus
• ● Proven track record of leading successful IND submissions and early-phase regulatory strategy for novel therapeutics
• ● Experience with regulatory strategy for biologics, including antibody or antibody-conjugate programs, strongly preferred
• ● Direct experience planning and leading interactions with the FDA; experience with EMA, MHRA, Health Canada, or other international agencies is a plus
• ● Strong knowledge of FDA and ICH regulations and guidance governing nonclinical, clinical, and CMC development of biologics
• ● Experience working alongside clinical development, nonclinical, and CMC functions to integrate data into regulatory documents and strategy
• ● Experience selecting and managing regulatory vendors, publishing partners, and CROs
• ● Strong written and verbal communication skills, with the ability to author clear, persuasive regulatory documents and present recommendations to leadership
• ● Experience advising or working within small, fast-paced biotechnology companies preferred

What we offer:

• ● Competitive consulting compensation
• ● A flexible engagement with a collaborative, small team
• ● The opportunity to contribute to innovative drug development efforts at an early-stage biotechnology company backed by highly regarded investors

Location

: Cambridge, MA (Remote / Hybrid flexible)