Associate Director, Global Regulatory Affairs

Merck Group • $135K — $202K *
Billerica, MA 01821In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Advanced degree required in a relevant field.
  • Minimum of 5 years in regulatory affairs strategy within drug development in the U.S.
  • Proven track record of successful FDA interactions for development and maintenance activities.
  • Experience with NDA/BLA submissions and strategic oversight with HA interactions.
  • Demonstrated ability to lead through a matrix organization effectively.
  • Exceptional written and verbal communication skills in English.

Responsibilities

  • Represent the region at the Global Regulatory Strategy Team (GRST).
  • Lead the regional regulatory sub-team for assigned projects.
  • Drive regulatory submissions and ensure compliance with development and maintenance plans.
  • Serve as the direct contact person for local Health Authorities (HAs) when applicable.
  • Contribute to developing local and global regulatory strategies for projects.
  • Provide leadership within a matrix organization to the Regional Regulatory sub-team.
  • Participate in cross-functional and Global Regulatory Affairs initiatives.

Benefits

  • Health insurance coverage.
  • Paid time off (PTO) policy.
  • Retirement contributions match.
  • Potential sales or performance-based bonuses.
Full Job Description
Scope: The Regional Regulatory Lead is responsible for the regulatory strategy and execution for their assigned projects in their region / country.

Responsibilities include, but are not limited to the following:
  • Represent and provide input for your respective region at the GRST. May provide direct input to the GPT in case of major region, particularly where the GRL is not in that region.
  • Lead the respective regional regulatory sub-team.
  • Drive the regulatory submission in your respective region. Ensure optimal planning in alignment with cross-functional team, and execution to plan for both development submissions and maintenance submissions to ensure ongoing compliance. Partner with Regulatory Project Management and Submission Management.
  • May act as direct contact to a local HA (e.g. FDA or EMA). Lead the direct interactions with the respective local HA in this case.
  • Contribute to the global regulatory strategy with local / regional strategy for assigned projects.
  • Matrix leadership role of respective Regional Regulatory ST.
  • Participate in cross-functional and GRA initiatives.


Minimum Qualifications
  • Advanced degree and at least 5 years of regulatory affairs strategy experience in drug development in the US.
  • Demonstrated successful interactions with FDA related to strategy and execution of development and maintenance activities.
  • Experienced strategist with a record of successful HA interactions with FDA or EMA including NDA / BLA activities.
  • Demonstrated strong matrix leader.
  • Excellent spoken and written English.


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: $135,300 - $202,900. 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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