Company
Pharma
RegulatoryAffairsTalentPool
Neural analysis suggests this role is
optimal for Mid candidates.
“Regulatory Affairs Talent Pool. Skills: regulatory strategy, regulatory submissions, product development, lifecycle management, health authority interactions. 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, ”
What You'll Achieve.
Opportunity to contribute to the development and approval of innovative healthcare products. Meaningful work supporting the advancement of therapies that positively impact patients' lives.
Industry & Context.
analytical thinking; problem-solving
Ability to thrive in a collaborative, fast-paced, and highly regulated environment.
What They're Looking For.
Must Have
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. Proficiency in English.
Nice to Have
Expertise in one or more regulatory disciplines, including regulatory strategy, labeling, regulatory operations, publishing, CMC, advertising and promotion, or health authority interactions. additional language skills considered an advantage depending on regional responsibilities.
What You'll Do.
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.
Provide regulatory guidance for advertising, promotional materials, and external communications.
Support Chemistry, Manufacturing, and Controls (CMC) activities.
Collaborate with health authorities and regulatory agencies.
Manage regulatory operations activities.
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.
How You'll Work.
Team & Collaboration
Partner with cross-functional teams to ensure regulatory considerations are integrated into development, commercialization, and post-approval activities. Ability to work across multidisciplinary teams. Cross-functional collaboration with experts across clinical development, regulatory, quality, manufacturing, and market access functions.
Communication Scope
communication; stakeholder management
Process & Methodology
manage multiple projects, deadlines
Full Job Description
## 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
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