Torrent Pharmaceuticals - Regulatory Affairs Specialist - MALTA

Description :

We are looking for an experienced Regulatory Affairs Specialist to support management and continuous improvement of regulatory processes.

Key Responsibilities :

• Preparation, review, and submission of variations to Marketing Authorizations (MAs), including safety-related variations, ensuring alignment with EU and national regulatory requirements.
• Oversee the tracking and management of regulatory deadlines, with a focus on proactive monitoring of product lifecycle management.
• Manage company license variations in coordination with internal stakeholders and authorities.
• Contribute to and lead initiatives in regulatory process design, optimization, and documentation, including authoring and maintaining SOPs.
• Act as a point of contact for cross-functional projects impacting regulatory compliance, including audits, inspections, and quality management reviews.
• Maintain and improve internal tracking systems and regulatory databases.

Job Requirements :

What we offer :

Interested candidates can apply with their updated cv.

(ref : iimjobs.com)