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:

- 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.