Full Job Description
The Regional Regulatory Manager is responsible for the execution of the regulatory strategy for their assigned projects and for supporting local regulatory activities in their region / country.
• Represent and provide input for your respective region at the GRST.
• Lead or support 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). 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 subteam.
• Participate in cross-functional and GRA initiatives.
Required Background
• Advanced degree (e.g., PhD, PharmD, MD, or equivalent).
• At least 1 year of regulatory affairs strategy experience in drug development in the US
• Demontrated successful interactions with FDA related to strategy and execution of development and maintenance activities.
• Demonstrated matrix leadership skill.
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: $103,900 - $155,900. 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
