Vice President Regulatory Affairs

VP or SVP Regulatory Affairs opportunity with an Oncology focused biotech in the Boston area!

Responsibilities:

• Build and drive Regulatory department/function by providing expert strategic insights and solutions toward successful product approvals.
• Develop and implement robust regulatory strategy and provide operational support across all clinical programs, while adhering to applicable US and ex-US regulatory, compliance, and quality standards.
• Prepare and deliver successful submissions/filings and outcomes with health authorities by providing effective leadership, oversight, direction, and planning.
• Develop timelines, milestones, and budgets in order to track progress, identify risks/constraints, and propose effective solutions for clinical programs.
• Prepare and contribute to reports and regulatory submissions, including identification and mitigation of potential critical issues, regulatory risks, to support decision-making on all product candidates.
• Work cross-functionally with various teams (CMC, Clinical, external consultants, etc.) to ensure regulatory plans are established and align with company objectives.

Qualifications:

• Advanced degree in life science related field with 12+ years in the biotechnology industry.
• Experience in an Executive level role, working with C-suite personnel.
• Oncology experience required.
• Proven experience leading major Regulatory submissions including CTA, BLA, etc.
• Ability to effectively liaise cross-functions with internal/external stakeholders, partners, vendors.
• Advanced working knowledge of the US Regulatory landscape including regulatory, compliance, and quality guidelines for oncology programs.

For full details on this opportunity, reach out to Kasey Dillon on kasey@peoplewithchemistry.com or 646-517-0307.