Drug Regulatory Affairs Executive

4 hours ago

Panchkula, Haryana, India Venus Remedies (VRL) Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Role & responsibilities

Job Summary:

We are looking for a skilled and motivated Senior Executive Drug Regulatory Affairs to support the registration and maintenance of injectable pharmaceutical products across ROW (Rest of the World) markets. The ideal candidate will have experience in compiling and submitting dossiers in accordance with country-specific regulatory guidelines, and will be responsible for handling end-to-end regulatory activities for injectable formulations in semi-regulated and emerging markets.

Key Responsibilities:

  • Prepare, compile, review, and submit high-quality regulatory dossiers (CTD/non-CTD formats) for injectable products in ROW markets (e.g., Latin America, Africa, CIS, Southeast Asia, Middle East).
  • Coordinate with cross-functional teams (R&D, QA, QC, Manufacturing, Packaging) to gather required technical documentation.
  • Ensure all submissions comply with the local regulatory requirements of target countries.
  • Liaise with in-country agents, partners, and regulatory consultants to facilitate product registrations and respond to queries from local health authorities.
  • Maintain a tracker/database of ongoing submissions, approvals, and renewals.
  • Prepare and submit post-approval changes, renewals, variations, and labeling updates as required.
  • Keep abreast of regulatory changes in ROW regions and update internal stakeholders accordingly.
  • Support in preparation of dossiers for WHO prequalification and other international tenders, where applicable.
  • Assist in audits, inspections, and regulatory due diligence activities.

Qualifications & Experience:

  • Education: B.Pharm / M.Pharm / M.Sc. in Regulatory Affairs, Pharmaceutical Sciences, or related discipline.
  • Experience: 3–7 years of relevant regulatory experience in injectable dosage forms for ROW markets.

  • Knowledge:

  • Strong understanding of regulatory frameworks in key ROW regions.

  • Familiarity with CTD, ACTD, and country-specific dossier formats.

  • Understanding of injectable-specific regulatory and GMP requirements.

  • Skills:

  • Excellent communication and coordination abilities.

  • Good documentation and technical writing skills.
  • Ability to work independently and handle multiple projects simultaneously.

Preferred Qualifications:

  • Experience in handling injectable dossiers for semi-regulated markets such as Latin America, Africa, CIS, or Southeast Asia.
  • Familiarity with WHO prequalification processes.
  • Hands-on experience with lifecycle management including variations, renewals, and post-approval changes.

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