Regulatory Affairs Executive

We are looking for a Regulatory Affairs Executive for our client place based at Greater Noida, Uttar Pradesh. An ideal will be responsible for supporting new drug product registrations and maintaining current drug product registrations for International Market. The role play a pivotal part in ensuring regulatory compliance, timely submissions, and successful approvals from Health department of the country.

Roles & Responsibilities:-

• Review and preparation of

  dossiers (ACTD, CTD, eCTD)

  as per specific country requirements
• Ensure dossier compliance with regulatory guidelines and maintain required quality standards.
• Preparation and verification of regulatory documents including

  COPP, FSC, PP, MA, LOA, SmPC, PIL

  etc.
• Review and verification of product permissions, PV, Stability, Specifications, STP, COA, PDR, BMR, BPR.
• Responsible for

  export artwork checking

  and regulatory approvals.
• Drafting, arranging, and filing of documents required for

  COPP applications

  .
• Coordination with internal departments and external stakeholders/vendors to resolve regulatory queries.
• Handling

  DMF, CDA filing, LOA’s

  , and vendor coordination for DMF-related queries and accreditation.
• Preparation of

  pre-audit checklists

  and participation in internal audits.
• Preparation of

  declarations

  as per customer/authority requirements.
• Responsible for arranging and dispatching

  export samples

  as per client requirement.
• Handling regulatory communication through

  emails, video calls, and meetings

  with overseas clients.
• Maintaining and updating all

  DRA document records

  related to export markets.

Qualifications & Skills:

• B.Pharm / M.Pharm / MSc in related discipline.
• 1–3 years of experience in

  Regulatory Affairs (Pharma Export)

  .
• Strong knowledge of

  ACTD, CTD, eCTD dossier preparation

  and international regulatory guidelines.
• Excellent communication skills (verbal & written) for international coordination.
• Detail-oriented with strong documentation and compliance skills.
• Ability to work independently and handle multiple projects simultaneously.

What We Offer:

• Opportunity to work on multiple

  international markets

  .
• Professional growth in global

  Regulatory Affairs domain

  .
• Collaborative work environment with exposure to leading clients and authorities.