Senior Manager Regulatory Affairs Labeling (Remote)

Role Overview & Key Functions:

Join our team as a Regulatory Affairs Manager and play a pivotal role in shaping the success of our global regulatory strategies. In this position, you will lead critical regulatory submissions, drive agency interactions, and ensure compliance with evolving regulatory standards. From managing labeling initiatives and regulatory intelligence projects to co-chairing cross-functional subteams, you will be at the forefront of advancing our drug development and commercialization efforts

• Accountable for the execution of regulatory strategies including, but not limited to, compiling regulatory submissions such as IND, CTA, Amendments, and support major submissions such as (s)NDA, MAA, variations, etc.
• Lead the compilation of Agency interaction documents such as Meeting Requests and Meeting Packages
• Act as the conduit between external functions and Regulatory Operations to ensure execution excellence of assigned submissions
• Lead Labeling Working Group for assigned submissions and responsible for USPI annotations and mockups
• Lead Regulatory initiatives including Regulatory Intelligence and Regulatory Science projects, compliance activities, and assigned tasks
• Maintain Regulatory Strategy Documents for assigned programs
• Co-chair Regulatory subteam with the Global Regulatory Lead
• Accountable for submissions such as Annual Reports and Renewals for assigned products

Candidate Profile & Requirements:

• Bachelor’s degree in a life science concentration
• 5+ years of experience and preferably with a Regulatory Affairs Postgraduate degree
• Good understanding of legislations, regulations, and policies that govern drug approvals and commercialization in the US, and preferably also in the EU
• Good understanding of relevant regulatory guidance documents that pertain to drug development and commercialization
• Experience with Regulatory Labeling such as leading Labeling Working Group and knowledge of USPI annotations and mock-ups
• Great understanding of Regulatory Intelligence tools and resources
• Excellent command of verbal and written English
• Ability to work with cross-functional teams and different project leads
• Proficient in the use of Microsoft Office, Adobe Acrobat, and SharePoint software.
• Ability to work on several projects at once while balancing multiple and overlapping timelines
• Careful attention to detail and accuracy