Drug Regulatory Affairs

3 days ago

Delhi Delhi, India Job Provider Baddi Full time

Responsibilities:

- Develop and implement regulatory strategies for drug development, registration, and commercialization in compliance with local and international regulations.
- Coordinate regulatory submissions and responses to regulatory agencies, ensuring accuracy, completeness, and timeliness.
- Maintain up-to-date knowledge of regulatory requirements, guidelines, and trends to inform regulatory strategy and ensure compliance.
- Collaborate with cross-functional teams, including Research and Development, Quality Assurance, Clinical Development, and Manufacturing, to support product development and registration activities.
- Provide regulatory guidance and support to internal stakeholders on matters related to product development, labeling, promotional materials, and post-market activities.
- Review and approve product labeling, packaging, and promotional materials to ensure compliance with regulatory requirements.
- Participate in regulatory agency meetings, inspections, and audits, representing the company's interests and addressing regulatory inquiries.
- Support regulatory compliance activities, including regulatory intelligence, risk assessments, and internal audits.
- Maintain regulatory documentation and databases, ensuring accuracy, completeness, and accessibility.

**Experience**:

- drug regualatory affair: 4 years (required)

Work Location: In person

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