Drug Regulatory Affairs

• Job Purpose To manage and coordinate domestic pharmaceutical regulatory affairs, manufacturing and product licensing requirements, regulatory submissions, government portal applications, product compliance documentation, artwork regulatory review, and regulatory correspondence for Rivpra Formulation Pvt. Ltd.
• Key Responsibilities

A. CDSCO & State Drug Authority Compliance

• Coordinate applicable regulatory applications, product permissions, approvals and correspondence with CDSCO and relevant State Drug Control Authorities.
• Maintain records of applicable manufacturing licences, product permissions, renewals, amendments and regulatory conditions.
• Coordinate responses to regulatory observations, queries, notices and inspection-related documentation with QA, Production and authorised management personnel.
• Track applicable statutory requirements and escalate regulatory risks promptly.

B. Government Portal Management

• Manage applicable applications and status tracking through CDSCO SUGAM.
• Coordinate relevant drug licensing workflows through ONDLS or the applicable state licensing system.
• Identify and coordinate applicable approvals through NSWS and other relevant government portals.
• Ensure accurate application data, supporting documents, submission records, acknowledgements and follow-up.
• Maintain a portal-wise application register, pending-action tracker and compliance calendar.

C. Domestic Product Regulatory Management

• Maintain a complete product regulatory master for products manufactured or proposed to be manufactured by Rivpra.
• Verify applicable product approvals, licence scope, approved compositions, strengths, dosage forms, specifications and regulatory documentation.
• Coordinate product additions, amendments, variations, renewals and other regulatory changes with the relevant authorities and clients.
• Ensure that product manufacturing and release activities are supported by the applicable approvals and authorised documentation.

D. Artwork & Labelling Compliance

• Coordinate regulatory review of cartons, labels, blister and strip foils, package inserts and other packaging materials.
• Verify proposed artwork text against applicable regulatory requirements, approved product details and documented client requirements.
• Coordinate artwork revisions and maintain version control and documented approvals.
• Work with the Artwork Designer, QA and relevant authorised personnel before artwork release.

E. Documentation & Compliance Monitoring

• Maintain controlled regulatory files, application dossiers, licences, approval letters and correspondence.
• Maintain renewal alerts, regulatory trackers and periodic management reports.
• Ensure records are complete, traceable and available for audits and inspections.
• Monitor applicable regulatory updates and communicate their potential impact to management and relevant departments.

F. Team Management & Coordination

• Supervise the Domestic Regulatory Executive and allocate work according to competency.
• Coordinate with QA, Production, Business Development, Supply Chain and external consultants.
• Provide timely updates on pending approvals, regulatory risks and application status.
• Ensure that no application, renewal or regulatory commitment is overlooked.
• Qualification & Experience
• B.Pharm or M.Pharm; a relevant regulatory affairs qualification is desirable.
• Preferably 5–8 years of pharmaceutical regulatory affairs experience, including hands-on domestic licensing and submission responsibilities.
• Experience in pharmaceutical formulation manufacturing or contract manufacturing is strongly preferred.
• Practical knowledge of CDSCO, State FDA procedures, SUGAM and relevant drug licensing portals.
• Working knowledge of product approvals, packaging labelling requirements, dossier documentation and regulatory compliance systems.
• Required Competencies
• Strong regulatory interpretation and documentation skills.
• Practical portal submission and application-tracking capability.
• Attention to detail and deadline management.
• Ability to identify regulatory gaps and escalate compliance risks.
• Cross-functional coordination and team supervision.

Note: Regulatory responsibilities and approval authority must follow applicable law, licence conditions and Rivpra’s approved quality-management procedures. The designation does not independently confer statutory authority on the employee.

Pay: ₹90,000.00 - ₹100,000.00 per month

Work Location: In person