Regeneron is seeking a highly motivated and experienced Associate Director of CMC Regulatory Sciences to join our global team.
This role is pivotal in leading post-approval commercial and global lifecycle management activities for Regeneron’s portfolio of commercial products.
The ideal candidate will have demonstrated leadership skills and the ability to direct a function effectively.
As an Associate Director of CMC Regulatory Sciences your remit will include the following :
Leading and managing the global CMC Regulatory Sciences Post-Approval Commercial team, providing strategic direction and oversight
Fostering a collaborative and innovative environment, encouraging team development and growth
Building and leading relationships with partners, regulators, and internal / external organizations
Establish key performance indicators and capacity of the team and manage resources across program portfolio according to business priority
Supervising post-approval regulatory activities, including new registrations, variations, and renewals
Interacting with regulatory authorities from US, Canada, and other international health agencies in support of CMC topics
Providing updates and reports to senior leadership on regulatory status and progress
Being accountable for the performance of the post-approval commercial team
Leading all aspects of development and execution of CMC regulatory strategies for new and existing products
Ensuring alignment of CMC regulatory strategies with overall business objectives
Ensuring the accuracy, quality, and clarity of written technical information / communications and ensure compliance with global regulatory requirements and guidelines
Monitoring changes in regulatory landscapes and industry trends and collaborate cross-functionally to drive improvements in the business
This role might be for you if :
You demonstrate leadership experience, with the ability to direct a global function effectively
You possess in-depth knowledge of global regulatory requirements and guidelines
You display strong technical skills and understanding of biopharmaceutical manufacturing processes and controls
You have strong strategic thinking and problem-solving skills
You possess excellent communication and interpersonal skills
You thrive in a multifaceted and fast-paced environment
To be considered for this opportunity you should have a BS / BA in Life Sciences or a related field and 10+ years of relevant work experience.
Relevant experience may be substituted in lieu of educational requirement.
LI-Onsite # #JOBSIEPR #IREADV
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