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
