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Torrent Pharmaceuticals - Regulatory Affairs Specialist - MALTA

Torrent Pharmaceuticals - Regulatory Affairs Specialist - MALTA

TORRENT PHARMACEUTICALS LTDEU, India
2 days ago
Job description

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 :

  • Master's degree in Pharmacy, Life Sciences, or a related field.
  • Minimum of 4 years of experience in Regulatory Affairs within the pharmaceutical industry.
  • Strong understanding of regulatory frameworks, including EU Variation Regulations, the HMA / CMDh guidelines, and national requirements.
  • Demonstrated experience within safety variations and regulatory lifecycle planning.
  • Ability to draft and implement regulatory SOPs, procedures, and internal workflows.
  • Strong organisational and project management skills, with attention to detail and a solutions-oriented approach
  • Valid work permit

    • What we offer :

  • Competitive remuneration package;
  • Comprehensive health insurance;
  • Hybrid working arrangements;
  • Safe and conducive working environment;
  • On-the-job training and professional development in a state-of-the-art facility equipped with the latest technologies.

    • Interested candidates can apply with their updated cv.

    (ref : iimjobs.com)

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