
Regulatory Affairs Expert
1 day ago
Job Description
We are seeking an experienced Regulatory Affairs expert to lead product registration submissions and reports. This role requires comprehensive knowledge of regulatory affairs, with the ability to manage complex projects.
Key Responsibilities
- Liaise with regulatory agencies for approval and compliance.
- Provide regulatory guidance during product planning and implementation.
- Ensure timely approval of new products and continued approval of marketed products.
- Represent the regulatory function in cross-functional teams.
- Advise on manufacturing changes, labeling, and regulatory requirements.
Requirements
- Degree in Pharmacy, Life Sciences, Biotechnology, or related field (Masters).
- Minimum 7 years of experience in Regulatory Affairs, preferably in pharmaceuticals, biologics, or medical devices.
- Demonstrated expertise in regulatory submissions, agency interactions, and lifecycle management.
Skills & Competencies
- Excellent understanding of regulatory guidelines and processes.
- Strong project management and problem-solving skills.
- Effective communication and stakeholder management abilities.
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