Regulatory Affairs Officer

5 years

4 - 6 Lacs

Posted:16 hours ago| Platform: SimplyHired logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Job Title: Senior Executive – Regulatory Affairs
Industry: Pharmaceuticals
Experience Required: 3–5 Years

Job Summary:

We are seeking a detail-oriented and proactive Senior Executive – Regulatory Affairs to ensure compliance with regulatory standards applicable to pharmaceutical products. The role involves managing end-to-end regulatory submissions, monitoring compliance with REACH, FSSAI, CDSCO, and other relevant national and international guidelines.

Key Responsibilities:

  • Prepare, review, and maintain dossiers, Product Information Files (PIFs), SDS,COAs, toxicological reports, CPSRs, and compliance statements.
  • Manage global regulatory submissions and compliance for international countries .
  • Liaise with international consultants/partners for local dossier filings and registrations.
  • Certifications & Sustainability Standards
  • Regulatory Intelligence & Training
  • Cross-Functional & Customer Support

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Desired Candidate Profile:

  • Bachelor’s/Master’s in Pharmacy, Chemistry, Life Sciences, or related field.
  • 3–5 years of Regulatory Affairs experience in cosmetic ingredients / personal care.
  • Strong knowledge of global cosmetic regulations: EU, US, Japan, Korea, China,ASEAN, LATAM, and Africa.
  • Hands-on experience with certification management: EcoVadis, COSMOS, Halal, Kosher, Vegan, Fairtrade, SEDEX.
  • Proven skills in dossier preparation, certification audits, and complianc submissions.
  • Strong organizational skills with ability to handle multiple country requirements simultaneously.
  • Excellent liaison and communication skills with consultants, auditors, and regulatory authorities.

Key Skills:

  • Global Regulatory Affairs (Cosmetics & Ingredients)
  • LATAM & ASEAN Regulatory Submissions (ANVISA, MERCOSUR, COFEPRIS, ASEAN Guidelines)
  • Certification Management (EcoVadis, COSMOS, Halal, Kosher, Vegan, Fairtrade,
  • SEDEX)
  • Audit & Inspection Handling (EcoVadis, GMP/ISO, Customer Audits)
  • Documentation & Dossier Preparation (PIFs, SDS, CPSRs, Toxicology, Safety Reports)
  • Cross-Functional Collaboration (R&D, Quality, Manufacturing, Sales)

Job Type: Full-time

Pay: ₹400,000.00 - ₹600,000.00 per year

Work Location: In person

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