Regulatory Affairs Manager

Job Purpose

Regulatory Affairs activities

Key Responsibilities

1. Regulatory Submissions & Strategy

• Plan and execute

  regulatory strategies

  for APIs across regulated and semi-regulated markets
• Prepare, review, and manage:

• US-DMF (Type II)

• EU-ASMF

• CEP / EDQM submissions

• Other country-specific API dossiers
• Handle

  new filings, amendments, annual updates, renewals, and variations

• Coordinate and respond to

  regulatory queries, deficiency letters, and assessment reports

2. Regulatory Lifecycle Management

• Manage

  post-approval changes

  including:
• Process, scale, or equipment changes
• Analytical method or specification changes
• Manufacturing site or raw material changes
• Evaluate

  change controls

  for regulatory impact and advise cross-functional teams
• Ensure continued compliance throughout the

  API lifecycle

3. Documentation & Technical Support

• Review and coordinate preparation of:
• CTD Module 3 (API sections)
• Quality Overall Summary (QOS)
• Stability data and trend reports
• Validation summaries (process, cleaning, analytical)
• Support

  customer regulatory queries, questionnaires, and audits

• Ensure consistency across

  QC, QA, R&D, and RA documentation

4. Regulatory Intelligence & Compliance

• Track updates to

  ICH, USFDA, EMA, EDQM, WHO, and other regulatory guidelines

• Assess regulatory changes and communicate impact to internal stakeholders
• Maintain regulatory trackers, commitments, and submission databases
• Ensure compliance with

  data integrity and cGMP commitments

5. Audit & Inspection Support

• Support

  regulatory inspections and customer audits

  from an RA perspective
• Coordinate preparation and submission of

  inspection responses

• Track and ensure closure of

  regulatory commitments post-inspection

6. Cross-Functional Coordination

• Work closely with

  QA, QC, R&D, Production, Engineering, and EHS

• Support

  technology transfer, scale-up, and commercialization activities

• Participate in

  risk assessments, change controls, and quality reviews

Qualifications

• M.Sc. (Chemistry) / B.Pharm / M.Pharm

• Formal exposure to

  API Regulatory Affairs

  is mandatory

Experience

• 58 years

  of experience in

  Regulatory Affairs for API manufacturing

• Strong hands-on experience with

  DMF / ASMF / CEP filings

• Experience supporting

  USFDA / EU / WHO inspections

• Exposure to

  regulated market customers

  preferred

Key Skills & Competencies

• Strong understanding of

  ICH guidelines and CTD structure

• Expertise in

  Module 3 (API) documentation

• Ability to assess regulatory impact of technical and process changes
• Strong documentation, coordination, and regulatory communication skills
• High attention to detail and compliance orientation

Safety & Compliance

• Ensure regulatory alignment for APIs manufactured under

  controlled / hazardous environments

• Coordinate with EHS and Quality teams on safety-related regulatory requirements