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Regulatory Affairs Executive

3 weeks ago

Andheri East Mumbai Maharashtra, India Career Strategy Solutions Full time

Seeking Drug Regulatory Affairs for a Company into Pharma Industry

**Key Responsibilities**:

- Research and stay updated on regulatory requirements and guidelines
- Coordinate with cross-functional teams to gather necessary documentation and information for regulatory filings
- Review and assess product labeling, packaging, and promotional materials to ensure compliance with regulatory standards and guidelines
- Maintain regulatory documentation and files in accordance with document control procedures and regulatory requirements
- Participate in regulatory inspections and audits, as required, and assist in responding to regulatory queries
- Assist in the development and implementation of regulatory strategies to support product development, registration, and commercialization goals
- Collaborate with external regulatory consultants, as needed, to address regulatory challenges and inquiries
- Coordination with manufacturer for the requirement of dossier/documents
- Preparation and coordination with external party for apostille and legalization work

**Qualifications**:

- Bachelor's degree in Pharmacy, Life Sciences, Regulatory Affairs, or related field
- Minimum of 2 to 3 years of experience in regulatory affairs

Pay: ₹300,000.00 - ₹400,000.00 per year

Schedule:

- Day shift

**Experience**:

- Regulatory reporting: 2 years (required)

Work Location: In person