Regulatory Affairs

3 days ago

Pune, Maharashtra, India Humano Forte Full time ₹ 3,00,000 - ₹ 7,00,000 per year

Key Responsibilities –

1. Regulatory Guidelines & Strategy

  • Monitor and interpret local/international regulations for APAC, LATAM, ROW, and Emerging markets.
  • Stay updated with FDA, ICH, WHO and country-specific guidelines for LATAM & Middle East.

2. Dossier Preparation & Submission

  • Prepare and submit registration dossiers (Checklist/CTD/ACTD) and market-specific documents.
  • Support new product, variation, and renewal submissions; ensure document accuracy and completeness.
  • Coordinate with regulatory agencies to obtain timely approvals and handle queries.

3. Documentation & Compliance

  • Maintain regulatory databases, track dossier progress and query, and ensure version control.
  • Collaborate with R&D, QA, QC, Sourcing, and BD teams to ensure lifecycle compliance.
  • Implement GMP and QMS principles and support audits and internal reviews.

4. Communication & Coordination

  • Act as a contact point for RTM Group of Companies and manage document flow.
  • Participate in meetings with internal teams, clients, or authorities to support regulatory planning.
  • Review administrative dossier parts (forms, declarations, LOAs, agreements) and Confidentiality/Supply Agreements.

5. Consulting & Business Development Support

  • Identify potential clients for regulatory services and assist in preparing tenders, proposals, and presentations.
  • Contribute to expanding the company's regulatory consulting presence in emerging markets.

6. Artwork, Samples & Reporting

  • Prepare and review artworks for packaging and labeling and coordinate printing approvals.
  • Manage product samples for submissions or exhibitions.
  • Assist in PMS and PSUR report preparation and monitor market feedback and regulatory updates

Skills & Competencies –


• Knowledge of CTD/ACTD dossier formats and global regulatory standards.

  • Strong documentation, coordination, and organizational skills.
  • Excellent communication, analytical, and problem-solving abilities.
  • Skilled in regulatory tracking tools, multitasking, and meeting deadlines.
  • Proven ownership and accountability in completing submissions.

Other Important Requirements –

  • Attention to detail with a strong sense of responsibility.
  • Ability to work independently as well as in a team environment.
  • Willingness to learn and adapt to evolving regulatory requirements.

Job Type: Full-time

Pay: ₹300, ₹700,000.00 per year

Application Question(s):

  • Do you have experience into pharmaceutical sector?

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