Professional training

Health insurance

Flexible working hours

Wellness programs

Torrent Pharma (Malta) Limited

&lt;p&gt;Our Regulatory Affairs team is growing, and we&#039;re seeking an experienced &lt;strong&gt;Regulatory Affairs Specialist &lt;/strong&gt;to play a key role in managing and continously improving our regulatory processes. &lt;/p&gt;
&lt;p&gt;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Key Responsibilities:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Preparation, review, and submission of variations to Marketing Authorizations (MAs), including safety-related variations, ensuring alignment with EU and national regulatory requirements.&lt;/li&gt;
&lt;li&gt;Oversee the tracking and management of regulatory deadlines, with a focus on proactive monitoring of product lifecycle management.&lt;/li&gt;
&lt;li&gt;Manage company licence variations in coordination with internal stakeholders and authorities.&lt;/li&gt;
&lt;li&gt;Contribute to and lead initiatives in regulatory process design, optimization, and documentation, including authoring and maintaining SOPs.&lt;/li&gt;
&lt;li&gt;Act as a point of contact for cross-functional projects impacting regulatory compliance, including audits, inspections, and quality management reviews.&lt;/li&gt;
&lt;li&gt;Maintain and improve internal tracking systems and regulatory databases.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Candidate Profile&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Education: &lt;/strong&gt;Master&#039;s degree in Pharmacy, Life Sciences, or a related field.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Experience: &lt;/strong&gt;Minimum of 4 years of experience in Regulatory Affairs within the pharmaceutical industry.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Skills:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Strong understanding of regulatory frameworks, including EU Variation Regulations, the HMA/CMDh guidelines, and national requirements.&lt;/li&gt;
&lt;li&gt;Demonstrated experience with safety variations and regulatory lifecycle planning.&lt;/li&gt;
&lt;li&gt;Ability to draft and implement regulatory SOPs, procedures, and internal workflows.&lt;/li&gt;
&lt;li&gt;Strong organizational and project management skills, with attention to detail and a solutions-oriented approach&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Applicant must be in possession of a valid work permit.&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Benefits&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Competitive remuneration package;&lt;/li&gt;
&lt;li&gt;Comprehensive health insurance;&lt;/li&gt;
&lt;li&gt;Hybrid working arrangements;&lt;/li&gt;
&lt;li&gt;Safe and conducive working environment;&lt;/li&gt;
&lt;li&gt;On-the-job training and professional development in a state-of-the-art facility equipped with the latest technologies.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;About Torrent Pharma Malta&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;&lt;em&gt;Torrent Pharma (Malta) Ltd is a subsidiary of Torrent Pharmaceuticals Limited, one of the leading pharmaceutical companies in India. Having a widespread global presence in over 40 countries, Torrent Pharmaceuticals is deemed as the flagship Company of the Torrent Group.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;&lt;em&gt;Torrent Pharma (Malta) was established in 2021 with a strategic purpose to serve as a central hub for Torrent&#039;s sustained growth within the European market. The company fosters an environment where passion meets potential.&lt;/em&gt;&lt;/p&gt;

Regulatory Affairs Specialist

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English - Full professional proficiency (Required)

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