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Torrent Pharma (Malta) Limited

&lt;p&gt;We are looking for a highly experienced &lt;strong&gt;Deputy Regulatory Affairs Manager - EU Lifecycle Management&lt;/strong&gt; to support our growing EU Regulatory Affairs function.&lt;/p&gt;
&lt;p&gt;This is a senior, hands-on role focused on EU post-authorisation lifecycle management, including safety-related and CMC-related regulatory activities.&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;Manage and support EU lifecycle submissions, including Type IA, IAIN, IB and Type II variations.&lt;/li&gt;
&lt;li&gt;Provide regulatory strategy for variation classification, grouping, work-sharing, implementation dates and submission planning.&lt;/li&gt;
&lt;li&gt;Support safety-related lifecycle updates, including Product Information updates, RMP-related changes, PSUR outcomes, referrals and reference product updates.&lt;/li&gt;
&lt;li&gt;Support CMC lifecycle changes, including manufacturing site changes, analytical methods, specifications, stability, suppliers, packaging, batch release and testing sites.&lt;/li&gt;
&lt;li&gt;Prepare, review and coordinate SmPC, labelling and package leaflet updates.&lt;/li&gt;
&lt;li&gt;Support responses to authority questions, validation issues and clock-stops.&lt;/li&gt;
&lt;li&gt;Liaise with corporate RA teams, internal departments, external partners, consultants and regulatory authorities.&lt;/li&gt;
&lt;li&gt;Mentor RA team members and support development of RA procedures, trackers and working practices.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Requirements:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Degree in Pharmacy, Life Sciences, Pharmaceutical Sciences, Chemistry or related discipline.&lt;/li&gt;
&lt;li&gt;Minimum 10 years’ Regulatory Affairs experience within the pharmaceutical industry.&lt;/li&gt;
&lt;li&gt;Strong hands-on experience in EU post-authorisation lifecycle management.&lt;/li&gt;
&lt;li&gt;Experience with both safety-related and CMC-related variations.&lt;/li&gt;
&lt;li&gt;Good knowledge of DCP, MRP and national procedures.&lt;/li&gt;
&lt;li&gt;Strong understanding of EU variation requirements, CMDh/HMA guidance, eAF requirements and regulatory submission processes.&lt;/li&gt;
&lt;li&gt;Experience reviewing submissions and identifying regulatory gaps before filing.&lt;/li&gt;
&lt;li&gt;Excellent organisational, communication and problem-solving skills.&lt;/li&gt;
&lt;li&gt;Fluent written and spoken English.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Preferred Experience:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Experience with generic medicinal products.&lt;/li&gt;
&lt;li&gt;Experience with multi-country EU regulatory portfolios.&lt;/li&gt;
&lt;li&gt;Experience with eCTD lifecycle submissions and electronic submission systems.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;What We Offer:&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;Professional development and training opportunities.&lt;/li&gt;
&lt;li&gt;Exposure to a broad European pharmaceutical portfolio.&lt;/li&gt;
&lt;li&gt;Opportunity to contribute to the development of a growing EU Regulatory Affairs function in Malta.&lt;/li&gt;
&lt;/ul&gt;

Deputy Regulatory Affairs Manager - EU Lifecycle Management

&lt;p&gt;We are seeking an experienced &lt;strong&gt;Regulatory Affairs Specialist&lt;/strong&gt; to support our growing EU Regulatory Affairs function.&lt;/p&gt;
&lt;p&gt;This role is focused on EU post-authorisation lifecycle management, including safety-related and CMC-related regulatory activities.&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;Prepare, review and support EU lifecycle submissions, including Type IA, IAIN, IB and Type II variations.&lt;/li&gt;
&lt;li&gt;Support variation classification, grouping, worksharing, implementation dates and submission planning.&lt;/li&gt;
&lt;li&gt;Support safety-related lifecycle updates, including Product Information updates, RMP-related changes, PSUR outcomes, referrals and reference product updates.&lt;/li&gt;
&lt;li&gt;Support CMC lifecycle changes, including manufacturing site changes, analytical methods, specifications, stability, suppliers, packaging, batch release and testing sites.&lt;/li&gt;
&lt;li&gt;Prepare, review and coordinate SmPC, labelling and package leaflet updates.&lt;/li&gt;
&lt;li&gt;Support renewals, regulatory commitments and lifecycle tracking activities.&lt;/li&gt;
&lt;li&gt;Prepare and support responses to authority questions, validation issues and clock-stops.&lt;/li&gt;
&lt;li&gt;Liaise with corporate RA teams, internal departments, external partners, consultants and regulatory authorities.&lt;/li&gt;
&lt;li&gt;Maintain RA trackers, submission plans and regulatory documentation.&lt;/li&gt;
&lt;li&gt;Contribute to the development of RA procedures, templates and working practices.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Requirements:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Degree in Pharmacy, Life Sciences, Pharmaceutical Sciences, Chemistry or related discipline.&lt;/li&gt;
&lt;li&gt;Minimum 5 years’ Regulatory Affairs experience within the pharmaceutical industry.&lt;/li&gt;
&lt;li&gt;Hands-on experience in EU post-authorisation lifecycle management.&lt;/li&gt;
&lt;li&gt;Experience with safety-related and/or CMC-related variations.&lt;/li&gt;
&lt;li&gt;Good knowledge of DCP, MRP and national procedures.&lt;/li&gt;
&lt;li&gt;Understanding of EU variation requirements, CMDh/HMA guidance, eAF requirements and regulatory submission processes.&lt;/li&gt;
&lt;li&gt;Ability to review regulatory documentation and identify gaps before submission.&lt;/li&gt;
&lt;li&gt;Excellent organisational, communication and problem-solving skills.&lt;/li&gt;
&lt;li&gt;Fluent written and spoken English.&lt;/li&gt;
&lt;li&gt;Eligibility to work in Malta / EU.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Preferred Experience:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Experience with generic medicinal products.&lt;/li&gt;
&lt;li&gt;Experience with multi-country EU regulatory portfolios.&lt;/li&gt;
&lt;li&gt;Experience with eCTD lifecycle submissions and electronic submission systems.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;What We Offer:&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;Professional development and training opportunities.&lt;/li&gt;
&lt;li&gt;Exposure to a broad European pharmaceutical portfolio.&lt;/li&gt;
&lt;li&gt;Opportunity to contribute to the development of a growing EU Regulatory Affairs function in Malta.&lt;/li&gt;
&lt;/ul&gt;

Regulatory Affairs Specialist – EU Lifecycle Management

&lt;p&gt;We are currently looking for a &lt;strong&gt;Senior Quality Assurance Officer (Quality Operations) &lt;/strong&gt;to join our team.&lt;/p&gt;
&lt;p&gt;In this role, you will play a pivotal role in upholding our commitment to quality and compliance. You will collaborate with a cross-functional team to ensure that Batch Documentation Package required for Batch Certification activities adhere to GMP standards, company procedures, and regulatory guidelines.&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;Support the maintenance and continuous improvement of the Quality Management System (QMS) in compliance with GMP requirements and regulatory standards.&lt;/li&gt;
&lt;li&gt;Assist the Qualified Person (QP) with batch certification activities, including the review of batch documentation to ensure compliance with approved product dossiers and marketing authorisations.&lt;/li&gt;
&lt;li&gt;Collaborate with Contract Manufacturing Organisations (CMOs) and internal stakeholders to resolve documentation issues and support the timely closure of deviations, CAPAs, and change controls.&lt;/li&gt;
&lt;li&gt;Manage quality-related activities including Product Quality Reviews (PQRs), market complaints, audit documentation, change evaluations, and QP declarations in accordance with company procedures.&lt;/li&gt;
&lt;li&gt;Participate in self-inspections and external audits, providing quality assurance support to maintain compliance and drive continuous improvement.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Job Requirements:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Degree in a scientific field (Chemistry, Pharmacy, or related discipline)&lt;/li&gt;
&lt;li&gt;Minimum of 4 years of experience in pharmaceutical quality assurance or a related field&lt;/li&gt;
&lt;li&gt;Demonstrated expertise in GMP principles and regulatory requirements&lt;/li&gt;
&lt;li&gt;Strong QA skills and meticulous attention to detail&lt;/li&gt;
&lt;li&gt;Excellent communication and interpersonal skills, with fluency in English (both written and verbal)&lt;/li&gt;
&lt;li&gt;Proactive, results-oriented, and capable of working independently and as part of a team&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;What we offer:&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;Continuous professional growth opportunities in a state-of-the-art Testing and Batch Certification Facility.&lt;/li&gt;
&lt;/ul&gt;

Senior Quality Assurance Officer (Quality Operations)

&lt;p&gt;We are seeking a &lt;strong&gt;Quality Control Technician&lt;/strong&gt; to join our growing team. In this role, you will perform routine quality control testing and laboratory support activities within a GMP-compliant chemistry laboratory, helping to ensure the quality and compliance of finished pharmaceutical products.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;What We&#039;re Looking For:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;A diploma in a scientific, technical, or related field would be considered an asset.&lt;/li&gt;
&lt;li&gt;Previous experience in a laboratory, manufacturing, or other regulated environment will be considered an advantage.&lt;/li&gt;
&lt;li&gt;Strong attention to detail, with excellent organisational and time-management skills.&lt;/li&gt;
&lt;li&gt;Good written and verbal communication skills in English.&lt;/li&gt;
&lt;li&gt;Ability to work accurately, follow procedures, and maintain high-quality standards.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;What we offer:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Competitive remuneration package with regular reviews and salary progression.&lt;/li&gt;
&lt;li&gt;Continuous professional development opportunities in a state-of-the art, brand-new laboratory equipped with the latest technologies.&lt;/li&gt;
&lt;li&gt;Comprehensive health insurance.&lt;/li&gt;
&lt;/ul&gt;

Quality Control Technician

&lt;p&gt;We are looking for a motivated and experienced &lt;strong&gt;Senior QC Analyst&lt;/strong&gt; to join our growing team. In this role, you will work in a GMP-compliant chemistry laboratory, where your expertise will directly contribute to delivering high-quality finished products.&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;Prepare, standardise and label stock solutions and laboratory reagents as required.&lt;/li&gt;
&lt;li&gt;Perform finished product and purified water testing using approved methods and specifications.&lt;/li&gt;
&lt;li&gt;Ensure proper handling, qualification, and calibration of laboratory equipment, including supporting external contractors and maintaining accurate records.&lt;/li&gt;
&lt;li&gt;Maintain and review QC documentation, SOPs, logs, and registers to ensure ongoing compliance.&lt;/li&gt;
&lt;li&gt;Support QC investigations, including deviations, OOX results, and change controls, and where required provide guidance to junior analysts.&lt;/li&gt;
&lt;li&gt;Carry out other Quality Control-related duties as required.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Job Requirements:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Degree or diploma in a scientific field.&lt;/li&gt;
&lt;li&gt;Minimum of 3 years of experience in a pharmaceutical QC laboratory, with strong expertise in chromatographic techniques.&lt;/li&gt;
&lt;li&gt;Excellent attention to detail, well-organised, and able to prioritise tasks effectively.&lt;/li&gt;
&lt;li&gt;Excellent communication skills.&lt;/li&gt;
&lt;li&gt;Valid work permit.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;What we offer:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Competitive remuneration package with regular reviews and salary progression.&lt;/li&gt;
&lt;li&gt;Continuous professional development opportunities in a state-of-the-art, brand-new laboratory equipped with the latest technologies.&lt;/li&gt;
&lt;li&gt;Comprehensive health insurance.&lt;/li&gt;
&lt;/ul&gt;

There Are No Job Openings at Torrent Pharma (Malta) Limited At The Moment