Export Manager

1 week ago

Sector Panchkula Chandigarh, India Swastik Lifesciences Full time ₹ 15,00,000 - ₹ 25,00,000 per year

EXPORT Manager /Assistant Manager Regulatory Affairs

Expertise: Asian & African Countries

1. Regulatory Strategy & Compliance

Develop and implement regulatory strategies to ensure timely approvals for new products, variations, and renewals.

Ensure compliance with national and international regulatory requirements (e.g., PIC/s, EMA, WHO, ICH, etc.) across all stages of product development and manufacturing.

Interpret and communicate updated regulatory guidelines, notifications, and circulars to relevant internal departments.

2. Dossier Preparation & Submission

Oversee and review the preparation, compilation, and submission of regulatory dossiers (e.g., CTD/eCTD, ACTD formats) for new product registrations, site approvals, and product renewals.

Coordinate with cross-functional teams (R&D, QA, QC, Production, Packaging) to gather and validate required data for regulatory filings.

Ensure timely submission of regulatory applications and responses to queries from regulatory agencies.

3. Liaison with Regulatory Authorities

Act as the primary contact with regulatory bodies (e.g., CDSCO, State FDAs, and International agencies).

Facilitate product /site inspections, audits, and pre-approval inspections by regulatory agencies.

Handle communications, deficiency responses, and follow-ups to achieve approvals in a timely manner.

4. Product Lifecycle Management

Manage regulatory activities throughout the product lifecycle, including post-approval changes, labeling updates, renewals, and variations.

Monitor regulatory commitments and ensure timely compliance with all post-approval obligations.

5. Documentation & Record Maintenance

Maintain and control all regulatory documents, dossiers, and submission archives in an organized and secure manner.

Ensure all regulatory files are updated and readily available for inspections or audits.

6. Team Leadership & Training

Lead and mentor the regulatory affairs team to ensure smooth execution of regulatory activities.

Conduct internal training sessions to keep relevant departments updated with the latest regulatory guidelines and requirements.

7. Regulatory Intelligence & Risk Management

Monitor global regulatory trends, changes in legislation, and competitive intelligence to assess potential impacts on the organization.

Identify regulatory risks and develop proactive mitigation strategies.

8. Support for Business Development & Exports

Provide regulatory support for business development activities including due diligence, product portfolio expansion, and entering new markets.

Manage product registrations and renewals in various export markets through coordination with overseas agents/partners.

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