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)