Assistant Manager-Regulatory Affairs

Job Description

Assistant Manager – Regulatory Affairs

Company: RPG Active Pharma
Business: API Manufacturing
Location: Manufacturing Site (Hyderabad (Kamareddy))
Reporting to: Head – Regulatory Affairs
Experience: 8–10 years

Role Purpose

The Assistant Manager – Regulatory Affairs will be responsible for managing site-level regulatory activities and documentation for the API manufacturing facility and will work closely with the Central Regulatory Affairs team to ensure regulatory readiness, compliance and timely support for customer and health authority requirements.

The role will act as the key regulatory interface between the manufacturing site and the Central RA team , ensuring that site information, documents, changes and regulatory commitments are accurately captured, maintained and provided on time.

Key Responsibilities

1. Site Regulatory Compliance

• Own and coordinate day-to-day regulatory activities at the API manufacturing site.
• Ensure site practices, processes and documentation remain aligned with applicable regulatory requirements and registered commitments.
• Act as the primary regulatory interface between the manufacturing site and the Central Regulatory Affairs team.
• Maintain regulatory readiness of the site for customer, partner and health authority requirements.

2. Regulatory Documentation & Submissions

• Coordinate preparation, review and timely submission of site-specific inputs required for DMF / ASMF, CEP and other API regulatory submissions .
• Compile and provide accurate manufacturing, process, analytical, quality and facility-related information to Central RA.
• Ensure regulatory documents and supporting data provided by the site are complete, consistent, current and traceable.
• Support preparation and review of responses to regulatory queries and requests for additional information.

3. Change Control & Regulatory Impact Assessment

• Review site change controls from a regulatory perspective and assess potential impact on registered processes, specifications, manufacturing sites and regulatory filings.
• Identify changes requiring regulatory notification, variation or submission and coordinate with Central RA for appropriate action.
• Track regulatory commitments arising from approved changes and ensure timely implementation.
• Work closely with QA, Manufacturing, R&D and Technical teams to ensure regulatory implications are considered before implementation of significant changes.

4. Manufacturing & Process Changes

• Provide regulatory inputs for changes related to:
• Manufacturing processes
• Batch sizes
• Manufacturing equipment
• Manufacturing locations / areas
• Raw materials and starting materials
• Specifications and analytical methods
• Process parameters
• Packaging and storage conditions
• Support regulatory assessment of new products, process improvements, scale-up, technology transfer and site changes .

5. Regulatory Support for Quality & GMP

• Work closely with QA to assess the regulatory impact of deviations, OOS/OOT, CAPAs, investigations and product/process-related quality events .
• Support evaluation of significant quality events from a regulatory reporting / commitment perspective.
• Ensure regulatory requirements and registered commitments are considered during investigation and CAPA closure.
• Support maintenance of inspection-ready regulatory documentation.

6. Regulatory Inspection & Audit Support

• Provide regulatory support for health authority inspections, customer audits and regulatory assessments at the manufacturing site.
• Coordinate preparation of regulatory documents and information required during inspections.
• Support responses to regulatory observations and ensure timely closure of regulatory action items.
• Maintain inspection-readiness of site regulatory records and documentation.

7. Customer & Business Development Support

• Support customer-specific regulatory requirements in coordination with Central RA, Quality and Business Development.
• Respond to API regulatory questionnaires, technical queries, declarations and documentation requests.
• Provide regulatory inputs for new customer evaluations and business opportunities.
• Support customer audits and regulatory discussions where site-specific regulatory expertise is required.

8. Regulatory Intelligence

• Monitor relevant changes in global API regulatory requirements and guidelines applicable to the site's markets.
• Assess potential impact of regulatory changes on site processes, documentation and registered products.
• Communicate relevant regulatory developments to Central RA and concerned site functions.
• Support implementation of new regulatory requirements at the manufacturing site.

9. Regulatory Data & Tracking

• Maintain site-level trackers for:
• Regulatory submissions
• Queries
• Commitments
• Change controls
• Regulatory actions
• Customer requests
• Inspection observations
• Ensure timely follow-up and closure of regulatory actions.
• Maintain accurate records of regulatory approvals, commitments and correspondence.

10. Cross-functional Site Coordination

• Partner closely with Quality, Manufacturing, R&D, Technical, QC, Engineering, Supply Chain and Business Development to obtain and validate regulatory inputs.
• Participate in relevant site meetings and provide regulatory perspective on operational and technical decisions.
• Ensure regulatory requirements are understood by relevant site stakeholders.
• Drive timely closure of regulatory actions through effective coordination and follow-up.

11. Regulatory Readiness & Continuous Improvement

• Conduct periodic reviews of site regulatory documentation and identify gaps.
• Drive improvements in regulatory documentation, systems and processes at the site.
• Ensure the site remains audit- and inspection-ready from a regulatory perspective.
• Identify opportunities to strengthen coordination between the site and Central RA and improve turnaround time for regulatory deliverables.

Key Interfaces

The role will work closely with:

• Central Regulatory Affairs
• Quality Assurance / Quality Control
• Manufacturing / Operations
• R&D / Process Development
• Engineering
• Analytical / Technical teams
• Supply Chain
• Business Development / Commercial teams

Candidate Profile

• 8–10 years of experience in Regulatory Affairs within API / pharmaceutical manufacturing .
• Strong hands-on experience in site regulatory activities for API manufacturing .
• Good understanding of API regulatory documentation and submission requirements.
• Experience working with DMF / ASMF documentation and regulatory queries .
• Exposure to regulatory inspections and customer audits.
• Good understanding of GMP and the regulatory implications of manufacturing/process changes.
• Ability to interpret technical information and translate it into appropriate regulatory documentation.
• Strong coordination and follow-up skills, with the ability to work across multiple site functions.
• Should be detail-oriented, organised and comfortable working in a manufacturing environment.

Educational Qualification

B.Pharm / M.Pharm / M.Sc. / relevant Life Sciences or Pharmaceutical qualification.