Executive / Asst. Manager – Regulatory Affairs – Aneta Pharma

Job Title – Executive / Asst. Manager – Regulatory Affairs

Experience – 06 to 12 years of relevant experience in (ROW/EU/CIS Markets)

Qualification – B Pharm / M.Pharm

Location – Ahmedabad

Job responsibilities for this position include:

• Prepare, compile, and review regulatory dossiers for submission in ROW/EU/CIS markets.
• Ensure timely submission of product registration dossiers in compliance with applicable regional regulatory requirements.
• Liaise with health authorities, partners, and internal cross-functional teams for query responses and updates.
• Monitor changes in regulatory guidelines and proactively assess impact on product lifecycle.
• Support renewal and variation submissions for existing products.
•  Coordinate with internal departments such as QA, QC, R&D, and Production for required documentation.
• Maintain regulatory databases and documentation in an organized and audit-ready manner.
• Ensure compliance with all local and international regulatory requirements and company standards.

Knowledge & Skills:

• Strong understanding of regulatory guidelines and submission requirements for the target markets.
• Experience in handling product dossiers for both pharmaceutical formulations and APIs is preferred.
• Leadership and team management
• Strong problem – solving and decision-making abilities
• Excellent communication and coordination skills

Interested candidates can share their updated CVs on

WhatsApp: +91 7575809274
Email: hr@anetapharma.com