Regulatory Affairs Director
13 hours ago
Company Overview:
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT.
Estimated Salary: ₹900,000 per year
Job Description:
We are seeking an experienced Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs sub-function, you will be responsible for directing the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
Main Responsibilities:
- Direct the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
- Interact with regulatory agencies to expedite approval of pending registrations.
- Serve as a regulatory liaison throughout the product lifecycle.
- Participate in product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
- Ensure timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
- Serve as a regulatory representative to marketing, research teams and regulatory agencies.
- Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
Qualifications:
We require an Associate's degree and relevant experience in regulatory affairs.
Benefits:
Lifelancer offers competitive salary and benefits packages.
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