Apply on Employer Site

Bicycle Therapeutics · 1 day ago

Vice President, Head of Regulatory Affairs

Cambridge, MA

Full-time

Onsite

Director/Executive

$290K/yr - $365K/yr

Bicycle Therapeutics is a clinical-stage pharmaceutical company developing innovative medicines. The Vice President, Head of Regulatory Affairs will architect the global regulatory strategy, lead a high-performing team, and serve as a trusted advisor to the Executive team, ensuring successful commercialization of their drug portfolio.

BiotechnologyMedical DeviceTherapeutics

Responsibilities

You will lead, coach, and mentor the global Regulatory Affairs team, investing in their professional growth and fostering a culture of high performance and psychological safety

You will set clear strategic priorities for the function, ensuring its work is directly aligned with departmental and organizational objectives

You will champion the Bicycle Values, acting as a role model and embedding a culture of collaboration, accountability, and innovation within your team

You will be accountable for the global regulatory strategy for our entire portfolio, translating long-term corporate objectives into a cohesive and actionable regulatory roadmap

You will serve as a trusted advisor, coach, and strategic thought partner to the CEO and Executive team on all matters related to regulatory strategy, risk, and opportunity

You will guide assets from development through to successful launch and lifecycle management, providing expert counsel on all regulatory aspects of commercialization

You will be accountable for all critical interactions and negotiations with global health authorities, including the FDA and EMA

You will be accountable for the oversight, preparation, and submission of all major regulatory filings, including INDs, CTAs, NDAs, and MAAs

You will provide strategic regulatory input on all clinical development, non-clinical, and CMC programs to ensure optimal regulatory pathways

You will ensure robust regulatory compliance and best practices are embedded across the organization

You will build and scale the regulatory function, implementing the processes and systems required to support a growing, commercial-stage organization

You will stay at the forefront of the evolving global regulatory landscape and advise the business on the potential impact of new legislation and guidance

Qualification

Oncology experienceRegulatory affairs expertiseDrug development lifecycleFDA interactionsTeam leadershipExecutive communicationStrategic thinkingProblem-solving

Required

Oncology and/or Radiopharmaceutical experience

A proven track record of successfully bringing a drug product through to marketing approval and commercialization in a senior regulatory leadership role is essential

Extensive experience in regulatory affairs within the biotech or pharmaceutical industry, with a deep understanding of the full drug development lifecycle

Demonstrated experience leading, mentoring, and scaling a high-performing regulatory affairs team

Deep expertise in navigating global regulatory landscapes, with extensive experience leading direct interactions with the FDA and other major health authorities

Strong executive presence and communication skills, with the ability to act as a credible, influential advisor to an Executive team