Executive- Regulatory Compliance

Sun Pharmaceutical Industries, Inc.; Dewas; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd. in Dewas seeks an Executive - Regulatory Compliance to oversee regulatory activities ensuring product quality for export markets.

You will manage regulatory documentation, approvals, and change controls at the site, coordinating with vendors and internal teams to maintain compliance. The role demands a strong understanding of regulatory affairs SOPs and the ability to drive timely renewals and variations while supporting filings and regulatory commitments.

Qualifications

• Must have hands-on experience in regulatory compliance for pharmaceutical manufacturing.
• Experience in review/approval of regulatory documentation and change controls.
• Familiarity with regulatory SOPs and filings for regulatory affairs.

Responsibilities

• Responsible for regulatory compliance function at Dewas location.
• Review/Approval of exhibit/operational documents including Formulation Order Manufacturing Instruction, Packaging Order Packaging Instruction, Process Performance Qualification Protocols/Reports, Stability Protocol, Stability termination notes, Active pharmaceutical ingredient specifications, Finished Product Specifications, Packaging Material specifications, Raw Material specifications, Annual Product Review, Market diversion, Material code transfer, Equipment Equivalence certificates, Out specification/Trend investigation Protocol/Reports, Exhibit batch destruction Reports and Conditional release, etc.
• Arranging Registration Samples/Placebo/Working standard for filing.
• Verification of regulatory compliance/commitments of vendor.
• Review of RFC with respect to confirmation on regulatory compliance and supply continuation.
• Review of Approval Package/License Particular with respect to operational documents and circulation of Approval Package/License Particular /Quarantine tracker in plant.
• Alert mail coordination/circulation and Recipe Locking/Unlocking activity.
• Review and approvals of change controls and deviations.
• Support to filings, deficiencies, variations and Annual updates.
• To ensure regulatory compliance with respect to filing and approval.
• Tracking of regulatory approvals and implementations.
• Coordination for fulfillment of regulatory commitments.
• Participation in Quality review Board meetings at manufacturing locations.
• Ensure compliance with Regulatory affair SOPs.
• To ensure Business Continuity by providing inputs and strategies to ensure timely renewals and variations.
• To ensure Business Continuity by providing feedback for resolving issues and changes related to manufacturing process, equipment, material, quality, lab etc., through appropriate regulatory decisions and wherever needed coordinating for filings/approvals.
• To ensure Business Continuity by coordinating with country specific regulatory agencies to bring clarity on how to handle new issues in a productive manner and to provide differentiated solutions to problems.

Skills

Regulatory compliance

Documentation review

Vendor coordination

Job description

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Company: Sun Pharmaceutical Industries Ltd

Job Title:

Executive - Regulatory Compliance

Business Unit:

RBC

Job Grade

G12A

Location :

Dewas

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Job Summary:

The position is responsible for all regulatory activities as listed below and to assure the quality of SPIL’s products manufactured at Sun Pharmaceutical Industries Ltd for the export markets.

Essential Job Functions:

• Responsible for regulatory compliance function at Dewas location.
• Review/Approval of exhibit/operational documents including Formulation Order Manufacturing Instruction, Packaging Order Packaging Instruction, Process Performance Qualification Protocols/Reports, Stability Protocol, Stability termination notes, Active pharmaceutical ingredient specifications, Finished Product Specifications, Packaging Material specifications, Raw Material specifications, Annual Product Review, Market diversion, Material code transfer, Equipment Equivalence certificates, Out specification/Trend investigation Protocol/Reports, Exhibit batch destruction Reports and Conditional release, etc…
• Arranging Registration Samples/Placebo/Working standard for filing.
• Verification of regulatory compliance/commitments of vendor.
• Review of RFC with respect to confirmation on regulatory compliance and supply continuation.
• Review of Approval Package/License Particular with respect to operational documents and circulation of Approval Package/License Particular /Quarantine tracker in plant.
• Alert mail coordination/circulation and Recipe Locking/Unlocking activity.
• Review and approvals of change controls and deviations.
• Support to filings, deficiencies, variations and Annual updates.
• To ensure regulatory compliance with respect to filing and approval.
• Tracking of regulatory approvals and implementations.
• Coordination for fulfillment of regulatory commitments.
• Participation in Quality review Board meetings at manufacturing locations.
• Ensure compliance with Regulatory affair SOPs.
• To ensure Business Continuity by providing inputs and strategies to ensure timely renewals and variations.
• To ensure Business Continuity by providing feedback for resolving issues and changes related to manufacturing process, equipment, material, quality, lab etc., through appropriate regulatory decisions and wherever needed coordinating for filings/approvals.
• To ensure Business Continuity by coordinating with country specific regulatory agencies to bring clarity on how to handle new issues in a productive manner and to provide differentiated solutions to problems.

Job Requirements

Educational Qualification

Experience

Tenure : 3+ years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer:

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).