Associate Director, Global Regulatory Affairs

Merck•Billerica, MA

17h•Hybrid

About The Position

The Associate Director, Global Regulatory Affairs is responsible for developing and executing regulatory strategy and plans for assigned projects within their region/country, ensuring timely, compliant submissions and approvals, and effective cross-functional collaboration. Key responsibilities include, but are not limited to the following; Define and execute regional regulatory strategy and plan for designated oncology programs. Lead in-region regulatory submissions, lifecycle management, and maintenance of approvals. Manage interactions with regional health authorities and coordinate responses to agency queries. Collaborate with global/regional teams to align regulatory activities with program timelines and milestones. Ensure compliance with regional regulatory requirements, internal standards, and governance processes. Mentor and influence cross-functional team members within the region; promote regulatory excellence. Monitor evolving regional regulations and guidelines to anticipate impact on programs. Support labeling negotiations, post-approval commitments, and pharmacovigilance activities as needed. Contribute to risk assessment and mitigation planning across the regulatory spectrum.

Requirements

Advanced degree (e.g., PhD, PharmD, MD, or equivalent).
At least 5 years of experience in drug development and/or regulatory affairs, preferably Oncology.
Demonstrated ability to lead in a matrixed environment and coordinate multi-disciplinary teams.
Strong written and spoken English; proficiency in additional languages is a plus.

Nice To Haves

Strategic thinker with practical execution capabilities.
Excellent stakeholder management, negotiation, and influencing skills.
Ability to balance multiple priorities and manage regulatory risk.
Experience with regional submissions and lifecycle management in one or more of the following regions: US, EU (Germany/France), or IRL.
Customer-focus and commitment to scientific rigor.

Responsibilities

Define and execute regional regulatory strategy and plan for designated oncology programs.
Lead in-region regulatory submissions, lifecycle management, and maintenance of approvals.
Manage interactions with regional health authorities and coordinate responses to agency queries.
Collaborate with global/regional teams to align regulatory activities with program timelines and milestones.
Ensure compliance with regional regulatory requirements, internal standards, and governance processes.
Mentor and influence cross-functional team members within the region; promote regulatory excellence.
Monitor evolving regional regulations and guidelines to anticipate impact on programs.
Support labeling negotiations, post-approval commitments, and pharmacovigilance activities as needed.
Contribute to risk assessment and mitigation planning across the regulatory spectrum.