Regulatory Affairs Director
4 days ago
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT.
Salary InformationThe estimated annual salary for this role is ₹1,500,000 - ₹2,250,000.
Job DescriptionThis experienced professional will work under limited supervision to apply subject matter knowledge in the area of Regulatory Affairs.
- Direct development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
- Interact with regulatory agencies to expedite approval of pending registrations.
- Act as a regulatory liaison throughout the product lifecycle.
- Participate in product plan development, regulatory strategy, risk management, and chemistry manufacturing control (CMC).
- Evaluate new drugs, biologics, or medical devices and ensure continued approval of marketed products.
- Represent regulatory affairs to marketing, research teams, and regulatory agencies.
Main Responsibilities:
- Develop and maintain knowledge of global regulatory requirements.
- Maintain compliance with regulatory standards.
- Collaborate with cross-functional teams to address regulatory issues.
- Analyze data to inform regulatory strategies.
To be successful in this role, you should have an Associate Degree (± 13 years) and relevant experience in Regulatory Affairs.
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