Role: Senior Executive Regulatory Affairs Pharma Formulations Manufacturing
Industry Type: Pharmaceutical & Life Sciences
Department: Legal & Regulatory
Employment Type: Full Time, Permanent
Role Category: Legal & Regulatory - Other
UG: B.Pharma in Pharmaceutical Analysis and Quality Assurance
PG: M.Pharma in Pharmacy, MS/M.Sc(Science) in Chemistry
Position
Senior Executive Regulatory Affairs
Department
Regulatory Affairs
Reporting To
Director / Head û Regulatory Affairs
Location
Head Office:
VIP Pharmaceuticals Pvt. Ltd.
205, Vikas Tower, Community Centre, Sector-8, Rohini, Delhi û 110085
Travel Requirement: Periodic visits to the manufacturing facility at Village Manpura, Nalagarh, District Solan (H.P.) and visits to regulatory authorities/consultants whenever required.
Job Summary
The Senior Executive û Regulatory Affairs shall be responsible for managing regulatory affairs activities from the Delhi Head Office, including preparation and submission of regulatory dossiers, coordination with domestic and international regulatory authorities, obtaining regulatory approvals, and supporting export registrations. The incumbent shall work closely with the manufacturing plant for collection of technical documentation, coordination of regulatory compliance activities, and execution of plant-related regulatory assignments.
Key Responsibilities
1. Regulatory Dossier Preparation
- Prepare CTD/ACTD/eCTD dossiers for international registrations.
- Compile country-specific product registration dossiers.
- Prepare variation, renewal and amendment applications.
- Respond to regulatory deficiency letters within stipulated timelines.
2. Regulatory Documentation
- Prepare and review:
- Product dossiers
- Administrative documents
- Product specifications
- Manufacturing process summaries
- Stability summaries
- Validation summaries
- Technical data sheets
- Product information leaflets
- Labels and artworks
- GMP-related documentation
3. Regulatory Coordination
- Liaise with:
- CDSCO
- State Licensing Authorities
- Drug Controllers
- Export Promotion Councils
- Overseas Regulatory Authorities
- Regulatory Consultants
- Business Development Team
- Overseas Distributors
4. Plant Coordination
- Coordinate with QA, QC, Production, Warehouse, Purchase and R&D for collection of regulatory documents.
- Visit the manufacturing plant whenever required for:
- Regulatory documentation
- Product registration activities
- Audit preparation
- Regulatory inspections
- Document verification
- Label approvals
- Technical discussions
- Collection of manufacturing and quality records
5. Export Regulatory Support
- Support product registrations for export markets.
- Coordinate submission of documents required by customers and regulatory agencies.
- Prepare and manage documents such as:
- COPP
- FSC
- GMP Certificates
- Product Permission Documents
- Free Sale Documents
- Notarization and Apostille documentation (where applicable).
6. Artwork & Label Compliance
- Review packaging artworks for regulatory compliance.
- Verify statutory declarations and country-specific labeling requirements.
- Coordinate artwork approvals with Packaging Development and QA.
7. Product Lifecycle Management
- Manage:
- Product renewals
- Variations
- Change notifications
- Registration validity tracking
- Regulatory commitments
8. Regulatory Intelligence
- Monitor changes in:
- CDSCO Regulations
- WHO Guidelines
- ICH Guidelines
- Importing Country Requirements
- Communicate regulatory updates to concerned departments.
9. Record Management
- Maintain updated regulatory database.
- Maintain submission trackers.
- Archive dossiers and correspondence.
- Ensure proper document version control.
10. Cross Functional Coordination
Coordinate effectively with:
- Quality Assurance
- Quality Control
- Production
- Purchase
- Export Department
- Packaging Development
- Research & Development
- Business Development
- Logistics
Documentation Responsibility
Responsible for preparation, review and maintenance of:
- CTD / ACTD / eCTD Dossiers
- Product Registration Files
- COPP Documentation
- FSC Documentation
- GMP Documentation
- Technical Data Sheets
- Product Specifications
- Stability Data
- Validation Summaries
- Product Information Leaflets
- Labels & Packaging Artworks
- Country-Specific Registration Documents
- Regulatory Correspondence
- Product Registration Tracker
Key Performance Indicators (KPIs)
- Timely submission of regulatory dossiers.
- Number of successful product registrations.
- Timely closure of regulatory queries.
- Zero major documentation deficiencies.
- Timely completion of renewals and variations.
- Accuracy of regulatory documentation.
- Timely support to export and business development teams.
- Effective coordination with manufacturing plant.
- Compliance with applicable regulatory requirements.
- Maintenance of updated regulatory database.
Qualification
- B.Pharm / M.Pharm / M.Sc. (Chemistry/Pharmaceutical Sciences)
Experience
- 4û8 years of experience in Regulatory Affairs in a pharmaceutical manufacturing company.
- Experience in handling export registrations and regulatory documentation.
- Working knowledge of WHO-GMP and international registration requirements.
Technical Skills
- CTD/ACTD/eCTD dossier preparation.
- CDSCO regulatory procedures.
- WHO-GMP documentation.
- International product registration.
- Microsoft Excel, Word & PowerPoint.
- Strong documentation and drafting skills.
- Regulatory tracking and document management.
Behavioural Competencies
- Excellent communication skills.
- Strong documentation and drafting ability.
- High attention to detail.
- Analytical and problem-solving skills.
- Ability to manage multiple regulatory projects.
- Strong coordination and follow-up skills.
- Ability to work independently with minimal supervision.
- Willingness to travel to the manufacturing facility and regulatory authorities whenever required.
Working Conditions
- Based at the Delhi Head Office.
- Six-day working week.
- Periodic travel to the Baddi manufacturing plant and regulatory offices.
- Interaction with domestic and international customers, consultants, and regulatory authorities.
- May be required to travel on short notice depending on regulatory or business requirements.
Authority
The Senior Executive û Regulatory Affairs is authorized to:
- Coordinate directly with all departments for regulatory documentation.
- Communicate with domestic and overseas regulatory consultants.
- Follow up with regulatory authorities regarding submissions.
- Recommend corrective actions for regulatory compliance issues.
- Escalate delays affecting regulatory submissions and product registrations.