Director, Global Regulatory Affairs

US Diversity Job Search; Billerica (MA); On-site; USD 172,000 - 231,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Other perquisites

Job summary

US Diversity Job Search is seeking a Director of Global Regulatory Affairs to define and execute global regulatory strategies for designated oncology programs, ensuring timely, compliant approvals across geographies. Lead cross-functional teams and manage FDA/EMA interactions to optimize submissions and lifecycle management.

The role requires an advanced degree and at least 6 years regulatory experience, including 3+ years in Oncology, with strong leadership and communication skills.

Qualifications

• Advanced degree required (PhD/PharmD/MD) with regulatory expertise.
• Proven track record in regulatory strategy development for oncology.
• Strong written and spoken English; multilingual skills a plus.

Responsibilities

• Develop and execute global regulatory strategy for oncology programs.
• Lead regulatory submissions and lifecycle management across regions.
• Manage interactions with health authorities (FDA/EMA) for approvals and labeling.
• Provide regulatory input to portfolio teams and drive data-driven decisions.
• Lead a cross-functional team to align regulatory timelines and deliverables.
• Ensure compliance with global/regional regulations and internal governance.
• Mentor junior regulatory staff and promote regulatory excellence.
• Monitor regulatory landscape to adapt strategies to changes.
• Collaborate with patient- and science-focused teams to support milestones.

Skills

Strategic regulatory leadership

Cross-functional leadership

HA/FDA/EMA interactions

English communication

Education

Advanced degree (PhD/PharmD/MD)

Job description

Position Scope

The Director of Global Regulatory Affairs is responsible for defining and executing the global regulatory strategy for designated oncology programs, ensuring timely and compliant approvals across geographies. This role requires strong leadership in cross-functional teams and deep expertise in regulatory interactions with major health authorities.

Key accountabilities

• Develop and execute global regulatory strategy for oncology programs within the Oncology TA.
• Lead regulatory submissions and life-cycle management across multiple regions in collaboration with the global regulatory team.
• Manage and optimize interactions with health authorities (e.g., FDA, EMA) to facilitate approvals and label extensions.
• Provide strategic regulatory input to portfolio and program teams; influence decision-making with a data-driven approach.
• Lead a cross-functional, matrix-driven team to align on regulatory requirements, timelines, and deliverables.
• Ensure compliance with global/regional regulations, quality standards, and internal governance.
• Mentor and develop junior regulatory colleagues; foster a culture of regulatory excellence and proactive risk management.
• Monitor evolving regulatory landscape to anticipate impact on programs and adapt strategies accordingly.
• Collaborate with global patients- and science-focused teams to support program milestones and lifecycle planning.

Required background and qualifications

• Advanced degree (e.g., PhD, PharmD, MD, or equivalent).
• At least 6 years of relevant regulatory experience with at least 3 years in Oncology.
• Demonstrated track record as an effective strategy developer and HA/EMA/FDA interaction expert.
• Proven ability to lead in a matrixed, cross-functional environment.
• Strong written and spoken English communication skills; proficiency in other languages is a plus.
• Excellent project management and influencing skills; able to drive programs across complex organizations.

Desired skills and attributes

• Strategic thinker with a hands-on, execution-focused mindset.
• Strong stakeholder management and negotiation capabilities.
• Ability to manage competing priorities with a clear gaze on risk management and compliance.
• Experience with global regulatory submissions (eCTD/dossier delivery) and lifecycle planning.
• Patient-centric mindset and commitment to scientific rigor.

Location

This is an onsite role based in our Billerica, MA facility requiring and onsite presence at least 3 days per week.

Pay Range

Pay Range for this position: $171,600 - $230,900. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.

Benefits

Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here: https://careers.emdgroup.com/us/en/benefits

What we offer

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!