
Regulatory Affairs Specialist
4 days ago
This is a critical role in our organization, responsible for managing and supporting regulatory submissions to ensure compliance with global regulations.
The ideal candidate will have a deep understanding of CDSCO regulations, including the Drugs and Cosmetics Act, 1940, and related rules, guidelines, and circulars.
Key responsibilities include preparing, reviewing, and submitting regulatory applications to CDSCO and other regulatory agencies, as well as staying updated on Indian and global regulatory requirements and changes.
Additionally, this role requires strong interpersonal skills to interact with colleagues, superiors, and external stakeholders in a professional and collaborative manner.
Required skills and qualifications:
- Technical knowledge of drug development lifecycle, clinical trials, and pharmacovigilance regulations.
- Excellent writing and communication skills to prepare clear, concise, and accurate regulatory documents.
- Ability to analyze complex regulatory requirements and identify potential challenges.
- Problem-solving skills to find solutions to regulatory issues and address queries from CDSCO efficiently.
Benefits:
- Opportunity to work in a dynamic and innovative organization.
- Chance to develop expertise in regulatory affairs and contribute to the growth of the company.
- Competitive compensation package and comprehensive benefits.
Others:
- Full-time position with regular working hours.
- Occasional travel required.
- Base location: Bengaluru.
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