Regulatory Affairs Specialist

Our client, a clinical-stage biotechnology company based in Boston's Seaport District, is looking for a Regulatory Affairs Specialist to join their growing regulatory team. This role supports the development and execution of regulatory strategies for pipeline therapeutics across multiple indications. The position reports directly to the VP of Regulatory Affairs and works closely with cross-functional teams including R&D, clinical operations, and quality assurance.

The Regulatory Affairs Specialist will be responsible for preparing and managing submissions to the FDA and select international regulatory bodies. This includes INDs, NDAs, BLAs, and annual reports, as well as responses to agency requests and deficiency letters. The specialist will also review promotional and labeling materials to ensure compliance with applicable regulations.

This is an individual contributor role suited to someone with hands-on submission experience who can operate with moderate autonomy. The company is advancing two programs through Phase II trials, so the pace is active and timelines are firm. Strong project management discipline and clear written communication are essential to succeed here.

Responsibilities

• Prepare, compile, and submit regulatory filings to the FDA and applicable international agencies
• Manage regulatory submission timelines and maintain the submission tracking database
• Review product labeling, package inserts, and promotional materials for regulatory compliance
• Monitor evolving FDA guidance documents and ICH guidelines and communicate impacts to internal stakeholders
• Collaborate with clinical, quality, and CMC teams to gather documentation for submissions
• Respond to agency information requests and manage written correspondence
• Support regulatory due diligence activities for business development partnerships
• Maintain the regulatory information management system and ensure document version control

Requirements

• Bachelor's degree in life sciences, pharmacy, chemistry, or a related field; advanced degree preferred
• Minimum 5 years of regulatory affairs experience within the biotech or pharmaceutical industry
• Demonstrated experience authoring or contributing to FDA submissions including INDs, NDAs, or BLAs
• Working knowledge of ICH guidelines, GxP requirements, and 21 CFR Parts 312 and 314
• Strong written communication skills with the ability to synthesize complex scientific information
• Proven ability to manage multiple regulatory projects simultaneously under tight deadlines
• Familiarity with electronic submission standards (eCTD) and regulatory publishing tools
• RAC certification is a plus but not required

Benefits

• Competitive base salary with annual performance-based bonus
• Medical, dental, and vision insurance with low employee cost-share
• 401(k) plan with 4% company match and immediate vesting
• Flexible paid time off plus 12 company holidays
• Annual professional development stipend for conferences and continuing education
• Commuter benefits program including pre-tax transit and parking
• On-site fitness facility access
• Paid parental leave for primary and secondary caregivers