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Assistant/Deputy Manager – Regulatory Affairs

We are looking for a motivated and experienced qualified to join our Regulatory Affairs team as an Assistant Manager – Regulatory Affairs. This is a full time, in office Regulatory Affairs Assistant Manager role based in Hubli-Dharwad. Key Responsibilities:

Prepare, review, and compile regulatory dossiers for product registrations, renewals, variations, and post-approval submissions.

Ensure compliance with applicable regulatory requirements and guidelines across target markets.

Coordinate with cross-functional teams, including R&D;, Quality Assurance, Manufacturing, Clinical for timely regulatory submissions.

Manage lifecycle maintenance activities, including change controls, label updates, and regulatory commitments.

Respond to regulatory authority queries and support inspections, audits, and agency interactions.

Monitor evolving regulatory requirements and assess their impact on products and business operations.





Maintain regulatory databases and submission trackers to ensure timely execution of regulatory activities.

Qualifications & Experience:

Master's degree in Pharmacy, Life Sciences, Biotechnology, or a related field.

5–10 years of experience in Regulatory Affairs within the pharmaceutical, biopharmaceutical, or biologics industry.

Hands-on experience in dossier preparation and submissions in CTD/eCTD format.

Good understanding of ICH guidelines, global regulatory requirements, and product lifecycle management.

Strong communication, coordination, and project management skills.

Preferred Experience

Experience handling regulatory submissions for biologics, biosimilars, vaccines, or complex pharmaceutical products.

Exposure to interactions with health authorities and management of regulatory inspections/audits.

Knowledge of emerging markets, ASEAN, MENA, LATAM, EU, USFDA, or other international regulatory frameworks.

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📌 Regulatory Affairs Assistent Manager Dharwad
🏢 SHILPA BIOLOGICALS PRIVATE
📍 Dharwad