
Product Registration Specialist
1 week ago
The successful candidate will direct product registration submissions, progress reports, supplements, amendments, or periodic experience reports. They will interact with regulatory agencies to expedite approval of pending registrations and serve as a regulatory liaison throughout the product lifecycle.
Key Responsibilities:- Develop and implement regulatory strategies for product registration and approval.
- Collaborate with cross-functional teams, including marketing and research, to ensure timely approval of new drugs, biologics, or medical devices.
- Provide regulatory guidance on manufacturing changes, line extensions, technical labeling, and appropriate regulations.
- Ensure compliance with relevant regulatory requirements and maintain relationships with regulatory agencies.
- Bachelor's degree in a life science or related field is required.
- A minimum of 7 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
- Strong knowledge of regulatory requirements and procedures is essential.
- Excellent communication and interpersonal skills are necessary.
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