Associate Director, Global Regulatory Affairs

About the role

We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity to help patients at every stage of life. Joining our Healthcare team means becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

The Regional Regulatory Lead is responsible for the regulatory strategy and execution for their assigned projects in their region or country.

Responsibilities

• 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 Health Authority (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 or regional strategy for assigned projects.
• Matrix leadership role of respective Regional Regulatory ST.
• Participate in cross-functional and GRA initiatives.

Requirements

• 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 leadership.
• Excellent spoken and written English.

Schedule

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

Pay

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

• Health insurance
• Paid time off (PTO)
• Retirement contributions
• Other perquisites

For more information, visit our benefits page.