Job Description

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