Regulatory Affairs – -Immdiete Jioner Required

Job Responsibilities:

- Manage Regulatory Affairs activities within the assigned area of responsibility and ensure the implementation of appropriate and effective regulatory strategies.

- Maintain sound knowledge of ICH guidelines, CTD/eCTD requirements, and applicable regulatory guidelines.

- Assist in the preparation, compilation, review, and submission of regulatory dossiers and supporting documents.

- Coordinate with manufacturers to collect required documents and information for dossier preparation, review, and submission to the respective regulatory authorities.

- Follow up with manufacturing sites for registration samples, working standards, and impurities required for regulatory and laboratory analysis.

- Prepare and maintain monthly regulatory status reports, including the status of new registrations, re-registrations, renewals, and post-approval changes.

- Review artwork, labels, packaging materials, and package inserts in accordance with the requirements of the respective regulatory authorities.

- Maintain accurate, complete, and up-to-date regulatory documentation and records.

- Monitor changes and updates in regulatory requirements and communicate relevant changes to internal stakeholders.

- Provide regulatory input during product development, including review and approval of labeling, packaging, and promotional materials.

- Coordinate with international partners and regulatory stakeholders to ensure compliance with applicable regulatory requirements.

- Participate in or support manufacturing-site/factory inspections, audits, and regulatory visits as required.





- Coordinate with cross-functional teams to ensure timely completion of regulatory activities and submissions.

- Travel to manufacturing sites, regulatory meetings, industry events, and other locations as required for inspections and business purposes.

- Handle regulatory activities independently while ensuring accuracy, compliance, and timely completion of assigned responsibilities.

Qualifications & Experience

- B. Pharm / M. Pharm or equivalent qualification.

- Minimum 2 years of relevant experience in Regulatory Affairs, preferably with a reputed pharmaceutical company.

- Good knowledge of ICH guidelines, CTD dossier requirements, and regulatory submission procedures.

- Experience in dossier compilation, product registration, re-registration/renewals, and post-approval changes will be preferred.

- Good understanding of regulatory requirements related to labeling, artwork, packaging, and package inserts.

- Strong coordination and communication skills for working with manufacturers, regulatory authorities, international partners, and internal teams.

- Fluent in spoken and written English, with the ability to communicate effectively with regulatory bodies and international stakeholders.

- Ability to work independently, manage multiple regulatory activities, and meet submission timelines.

- Willingness and ability to travel to manufacturing sites, inspections, meetings, and other business locations as required.

Pay: ₹40,000.00 - ₹45,000.00 per month

Perks

- Flexible schedule

- Food provided

- Paid sick time

- Provident Fund

Education

- Master's (Required)

Experience

- regulaory: 8 years (Required)

Work Location: In person

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