Jobgether
Regulatory Affairs Talent Pool
TLDR
Support diverse regulatory strategies, submissions, and lifecycle activities across therapeutic areas within a collaborative, cross-functional team shaping global healthcare solutions.
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.
- 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 submissions.
- Knowledge of regulatory processes throughout the product development and lifecycle management stages.
- Excellent organizational skills with the ability to manage multiple projects and deadlines simultaneously.
- Strong analytical thinking, attention to detail, and problem-solving capabilities.
- Effective communication and stakeholder management skills with the ability to work across multidisciplinary teams.
- Ability to thrive in a collaborative, fast-paced, and highly regulated environment.
- Proficiency in English, with additional language skills considered an advantage depending on regional responsibilities.
- Remote work opportunities offering flexibility and improved work-life balance.
- Exposure to diverse regulatory projects across multiple therapeutic areas and global markets.
- Opportunity to contribute to the development and approval of innovative healthcare products.
- Collaborative and mission-driven environment focused on improving patient outcomes worldwide.
- Access to professional development opportunities and ongoing learning within the regulatory field.
- Cross-functional collaboration with experts across clinical development, regulatory, quality, manufacturing, and market access functions.
- Potential career growth opportunities across multiple regulatory specializations and global programs.
- Meaningful work supporting the advancement of therapies that positively impact patients' lives.
Requirements
Benefits
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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Benefits
Learning Budget
Access to professional development opportunities and ongoing learning within the regulatory field.
Remote-Friendly
Remote work opportunities offering flexibility and improved work-life balance.
Jobgether runs the largest remote job platform, effectively linking job seekers with over 200,000 flexible and remote opportunities that match their unique skills and preferences. Our focus is on enhancing the hiring process, ensuring efficiency while prioritizing the candidate experience, particularly in the growing health and wellness sector.
- Founded
- Founded 2020
- Employees
- 11-50 employees
- Industry
- Professional Services
Talent Pool