VP, Global Regulatory Strategy & IND Leadership

Boulevard Bio; Boston (MA); On-site; USD 320,000 - 520,000; Full time

Benefits offered by this job

Competitive compensation package

Comprehensive benefits

Equity opportunities

Job summary

A biotechnology company in Boston seeks a Vice President of Regulatory. This role involves leading the regulatory strategy and managing interactions with health authorities. The ideal candidate has over 12 years of regulatory affairs experience including INDs and a strong understanding of clinical development. Responsibilities include strategic development, regulatory submissions, and team leadership. A competitive compensation package is offered, including equity opportunities.

Qualifications

• 12+ years of regulatory affairs experience in biopharma/biotech.
• Experience leading regulatory strategy and health authority interactions.
• Strong understanding of clinical development and regulatory processes.

Responsibilities

• Develop and own global regulatory strategy for the company’s pipeline.
• Serve as the primary point of contact with regulatory authorities.
• Oversee preparation and submission of regulatory filings.
• Partner closely with various departments to align with regulatory requirements.
• Provide authorship and review of key regulatory documents.
• Anticipate regulatory risks and propose mitigation strategies.
• Establish regulatory processes and systems for a startup environment.
• Manage and mentor internal regulatory staff and external consultants.
• Monitor global regulatory guidelines and translate changes into guidance.

Skills

Regulatory affairs expertise

Communication skills

Cross-functional collaboration

Leadership

Education

Advanced degree in life sciences, pharmacy, or related field

Job description

A biotechnology company in Boston seeks a Vice President of Regulatory. This role involves leading the regulatory strategy and managing interactions with health authorities. The ideal candidate has over 12 years of regulatory affairs experience including INDs and a strong understanding of clinical development. Responsibilities include strategic development, regulatory submissions, and team leadership. A competitive compensation package is offered, including equity opportunities.