Drug Regulatory Affair

1 week ago

Chandigarh Chandigarh, India Maya Biotech PVT LTD Full time

**Position**: Drug Regulatory Affairs Executive
**Industry**: Pharmaceutical Manufacturing (Third-Party Manufacturer)
**Location**: Chandigarh, Baddi

**About Us**

We are a leading pharmaceutical company specializing in injectable formulations. With a strong commitment to quality and regulatory compliance, we provide innovative and high-quality solutions for pharmaceutical brands globally.

**Key Responsibilities**
- Independently prepare, compile, and review regulatory dossiers for export markets, ensuring compliance with country-specific regulatory requirements.
- Manage end-to-end regulatory submissions, including obtaining approvals for new product registrations, renewals, and variations.
- Maintain up-to-date knowledge of international regulatory guidelines (e.g., USFDA, EU GMP, WHO GMP, etc.) and ensure adherence to all relevant standards.
- Liaise with clients and regulatory authorities to address queries and ensure timely approvals.
- Coordinate with internal teams (e.g., quality assurance, production, R&D) to collect necessary documentation for dossier preparation.
- Track and manage regulatory timelines and deliverables to ensure smooth product registrations in multiple markets.
- Assist in the preparation and review of technical documents, including specifications, stability data, and validation reports.
- Support audits and inspections by regulatory bodies as required.

**Qualifications and Skills**
- **Experience**: Minimum 2-4 years in Drug Regulatory Affairs within the pharmaceutical industry, with a focus on injectables and third-party manufacturing.
- Proven ability to independently prepare and manage dossiers for export markets.
- Strong understanding of global regulatory requirements and guidelines.
- Excellent communication and interpersonal skills for effective collaboration with clients and regulatory bodies.
- Proficiency in documentation and attention to detail.
- **Education**: Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.

**Job Types**: Full-time, Permanent

Pay: ₹20,000.00 - ₹30,000.00 per month

Schedule:

- Morning shift

Work Location: In person

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