Vice President, Head of Regulatory Affairs

Bicycle Therapeutics•Cambridge, MA

1d•$290,000 - $365,000

About The Position

As a key member of the senior leadership team, your mission is to be the architect of Bicycle’s global regulatory strategy. You will lead a high-performing team, providing the vision and expertise required to navigate complex regulatory landscapes and successfully bring our innovative medicines from development through to commercialization. As a trusted advisor to the Executive team, you will be the primary interface with global health authorities, shaping a regulatory path that delivers on our ambitious corporate objectives.

Requirements

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.

Responsibilities

Lead, coach, and mentor the global Regulatory Affairs team, investing in their professional growth and fostering a culture of high performance and psychological safety.
Set clear strategic priorities for the function, ensuring its work is directly aligned with departmental and organizational objectives.
Champion the Bicycle Values, acting as a role model and embedding a culture of collaboration, accountability, and innovation within your team.
Be accountable for the global regulatory strategy for our entire portfolio, translating long-term corporate objectives into a cohesive and actionable regulatory roadmap.
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.
Guide assets from development through to successful launch and lifecycle management, providing expert counsel on all regulatory aspects of commercialization.
Be accountable for all critical interactions and negotiations with global health authorities, including the FDA and EMA.
Be accountable for the oversight, preparation, and submission of all major regulatory filings, including INDs, CTAs, NDAs, and MAAs.
Provide strategic regulatory input on all clinical development, non-clinical, and CMC programs to ensure optimal regulatory pathways.
Ensure robust regulatory compliance and best practices are embedded across the organization.
Build and scale the regulatory function, implementing the processes and systems required to support a growing, commercial-stage organization.
Stay at the forefront of the evolving global regulatory landscape and advise the business on the potential impact of new legislation and guidance.

Benefits

Flexible working environment
Competitive reward including annual company bonus
Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company
Health and Dependent Care Flexible Spending Accounts
401(k) plan with a 4% Company match and immediate vesting
Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days
Employee assistance program
Employee recognition schemes
10 Company holidays
Competitive Family Leave Policy
Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.