Director, Global Regulatory Affairs

Merck Group • $171K — $230K *
Billerica, MA 01821In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
3 days ago
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Job Overview by Ladders

Qualifications

  • Advanced degree (PhD, PharmD, MD, or equivalent) required.
  • Minimum 6 years of regulatory experience, including 3 years in Oncology.
  • Proven track record in leading strategies and interacting with health authorities (FDA, EMA).
  • Experience in a matrixed, cross-functional environment is essential.
  • Strong English communication skills; proficiency in additional languages is advantageous.
  • Demonstrated project management and influencing capabilities.

Responsibilities

  • Develop and execute global regulatory strategies for oncology programs.
  • Lead regulatory submissions and manage life-cycle processes across multiple regions.
  • Optimize interactions with health authorities to secure approvals and label extensions.
  • Provide strategic regulatory input to influence decision-making in program teams.
  • Align cross-functional teams on regulatory requirements and timelines.
  • Ensure compliance with all relevant regulations and governance standards.
  • Mentor junior regulatory colleagues and promote a culture of excellence.

Benefits

  • Health insurance coverage.
  • Paid time off (PTO).
  • Retirement contributions.
  • Eligible for sales or performance-based bonuses.
  • Additional job-related perks.
Full 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 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 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

About Merck Group

Merck Group Careers

There has never been a more opportune time to join Merck Group, a leading science and technology company in healthcare, life science, and performance materials. Merck Group offers a plethora of job opportunities that cater to a variety of skills and professional aspirations, making it an ideal environment for both seasoned experts and those at the start of their career journey.

Work You’ll Do

At Merck Group, every team member contributes to breakthrough innovations in healthcare, life sciences, and electronics. The company's commitment to diversity and innovation fuels its leadership in various sectors, driving growth and transformation globally. Merck Group’s career paths are diverse, offering positions that challenge individuals to use their skills in new ways every day, supported by robust training programs and development opportunities.

Explore Job Opportunities and Growth

Merck Group is not just about jobs; it's about building a career. With a vast array of positions, from research and development to marketing and sales, the company is keen on hiring and nurturing talent to lead industry transformation. Merck Group’s dedication to professional growth is evident in its comprehensive benefits package and performance management processes that aim to maximize individual potential.

Internship Programs

Starting with an internship at Merck Group can be a pivotal step in securing a prosperous career. Interns gain invaluable industry experience, working alongside seasoned professionals and engaging in projects that offer real-world applications of their studies. Internships often lead to full-time employment opportunities, providing a seamless transition from education to professional employment.

Inclusive Culture and Leadership

Merck Group is proud of its inclusive culture that embraces diversity and fosters an environment where all employees can thrive. The company’s leadership is committed to creating a workplace where diverse ideas lead to innovative outcomes. Merck Group also offers diversity training to ensure all team members are equipped to contribute to the company’s inclusive goals.

Networking and Professional Development

Employees at Merck Group are encouraged to engage in networking and professional development activities that enhance their career trajectories. The company hosts various networking events, workshops, and seminars that are designed to hone skills and foster connections within the industry. Leadership development programs are also a cornerstone, preparing employees for future roles of increased responsibility.

Stay Connected with Merck Group Careers

Interested candidates can explore open positions that match their skills and interests through the Merck Group careers page. The company values curious, creative, and solution-driven team players who are eager to make an impact.

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Merck Group is continuously looking for individuals who are ready to drive innovation and lead in the global marketplace. Whether through full-time positions, internships, or leadership roles, Merck Group offers a career path filled with opportunities for growth, learning, and leadership.
Learn more about Merck Group
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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