RegulatoryAffairsTalentPool

## Accountabilities Support the development and execution of regulatory strategies to facilitate successful product development, registration, and lifecycle management activities. Prepare, review, coordinate, and manage regulatory submissions and documentation in compliance with regional and global regulatory requirements. Contribute to labeling development, maintenance, and compliance activities, ensuring product information remains accurate and aligned with regulatory standards. Provide regulatory guidance for advertising, promotional materials, and external communications to ensure compliance with applicable regulations. Support Chemistry, Manufacturing, and Controls (CMC) activities by contributing regulatory expertise throughout product development and manufacturing processes. Collaborate with health authorities and regulatory agencies, supporting responses, communications, submissions, and approval processes. Manage regulatory operations activities, including submission publishing, document management, tracking, and compliance oversight. Partner with cross-functional teams to ensure regulatory considerations are integrated into development, commercialization, and post-approval activities. Monitor regulatory changes, emerging guidelines, and industry trends to proactively assess potential impacts and opportunities. Requirements Bachelor's degree or higher in Life Sciences, Pharmacy, Chemistry, Biotechnology, Regulatory Affairs, or a related scientific discipline. Professional experience in regulatory affairs within the pharmaceutical, biotechnology, medical device, healthcare, or life sciences sectors. Expertise in one or more regulatory disciplines, including regulatory strategy, labeling, regulatory operations, publishing, CMC, advertising and promotion, or health authority interactions. Strong understanding of regional and global regulatory frameworks and submission requirements. Experience preparing, reviewing, and managing regulatory documentation and subm