Privately Held

Health and Wellness

Pharmaceuticals

English

Maltese

Torrent Pharma (Malta) Limited

&lt;p&gt;We are seeking an experienced and hands-on&lt;strong&gt; IT Operations Manager &lt;/strong&gt;to lead and maintain the company’s IT infrastructure, information systems, cybersecurity controls, and digital operations within a highly regulated pharmaceutical environment. The role forms part of middle management and is responsible for leading and developing a small IT team.&lt;/p&gt;
&lt;p&gt;&lt;/p&gt;
&lt;p&gt;This role combines technical leadership with operational responsibility and requires a practical individual capable of balancing infrastructure management, cybersecurity, business continuity, and regulatory requirements.&lt;/p&gt;
&lt;p&gt;Whilst pharmaceutical industry experience would be considered an asset, candidates from other regulated or ISO-driven environments will also be considered.&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 provide hands-on support for the company&#039;s IT infrastructure, systems, laboratory equipment, networks, and supporting services&lt;/li&gt;
&lt;li&gt;Oversee cybersecurity controls and information security activities&lt;/li&gt;
&lt;li&gt;Coordinate vulnerability management, patching, change management, and incident response activities&lt;/li&gt;
&lt;li&gt;Maintain business continuity, backup, and disaster recovery capabilities&lt;/li&gt;
&lt;li&gt;Coordinate with internal stakeholders, external suppliers, and managed service providers&lt;/li&gt;
&lt;li&gt;Support audits, risk assessments, and continual improvement activities&lt;/li&gt;
&lt;li&gt;Ensure compliance with company procedures and applicable regulatory requirements&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Key Requirements &amp;amp; Experience&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Minimum 5 years’ experience in a similar IT management or supervisory role within a regulated and structured environment&lt;/li&gt;
&lt;li&gt;Proven experience managing and developing a small team&lt;/li&gt;
&lt;li&gt;Strong understanding of IT infrastructure, networking, cybersecurity, and data integrity principles&lt;/li&gt;
&lt;li&gt;Understanding of cybersecurity governance, business continuity, disaster recovery, information security principles&lt;/li&gt;
&lt;li&gt;Experience managing external IT vendors, software providers, and service partners&lt;/li&gt;
&lt;li&gt;Experience supporting internal and external audits and regulatory inspections&lt;/li&gt;
&lt;li&gt;Strong communication, organisational, leadership, and problem-solving skills&lt;/li&gt;
&lt;li&gt;Familiarity with ERP, LIMS, QMS, or other regulated business systems will be considered an advantage&lt;/li&gt;
&lt;li&gt;Knowledge of ISO 27001, GMP, NIS2, or similar frameworks will be considered an advantage&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Key Personal Attributes&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Structured, process-driven, and detail-oriented&lt;/li&gt;
&lt;li&gt;Strong sense of leadership, accountability, integrity, and confidentiality&lt;/li&gt;
&lt;li&gt;Ability to operate effectively within formal procedures and regulated environments&lt;/li&gt;
&lt;li&gt;Hands-on approach with strong operational involvement.&lt;/li&gt;
&lt;li&gt;Practical and solution-oriented mindset capable of balancing governance requirements with operational efficiency&lt;/li&gt;
&lt;li&gt;Ability to work cross-functionally with Quality, Operations, Regulatory, and Supply Chain functions&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Strategic Role Contribution&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;The successful candidate will contribute to strengthening the company’s information security culture, digital maturity, and overall operational resilience as part of the company’s continued growth within regulated EU pharmaceutical operations.&lt;/p&gt;

IT Operations Manager

&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;