Regulatory Affairs Executive

Job Description:-

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.

Role & 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, LOAs, 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.

Preferred Candidate Profile:-

• B.Pharm / M.Pharm / MSc in related discipline.
• 13 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.

Perks and Benefits :- Best In the Industry

Job Types: Full-time, Permanent

Pay: ₹300,000.00 - ₹600,000.00 per year

Benefits:

• Health insurance
• Leave encashment
• Life insurance
• Provident Fund

Work Location: In person