Regulatory Affairs

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: ₹300,000.00 - ₹700,000.00 per year

Application Question(s):

• Do you have experience into pharmaceutical sector?