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Torrent Pharma (Malta) Limited

&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 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 looking for a detail-oriented and experienced Senior Quality Assurance Officer (Quality Management Systems &amp;amp; EOHS) to support the maintenance and continuous improvement of our Quality Management System (QMS) and Environment, Occupational Health &amp;amp; Safety (EOHS) Management System, ensuring continued compliance with applicable regulatory and company requirements.&lt;/p&gt;
&lt;p&gt;&lt;/p&gt;
&lt;p&gt;The role reports directly to the &lt;strong&gt;Quality Management Systems Manager&lt;/strong&gt;.&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, update and maintain SOPs/SOFs in accordance with company policies, EU cGMP requirements and applicable EOHS requirements.&lt;/li&gt;
&lt;li&gt;Support the preparation for regulatory and client audits and participate in the company&#039;s self-inspection programme.&lt;/li&gt;
&lt;li&gt;Maintain QA documentation, quality logs, document registers and associated records to ensure continued compliance.&lt;/li&gt;
&lt;li&gt;Assist in the investigation, follow-up and closure of deviations.&lt;/li&gt;
&lt;li&gt;Collaborate cross-functionally with internal departments to ensure that quality, regulatory and EOHS requirements are effectively integrated into company processes.&lt;/li&gt;
&lt;li&gt;Assist in the implementation and maintenance of the company&#039;s training programme and ensure that required employee training is appropriately managed and documented.&lt;/li&gt;
&lt;li&gt;Manage the Supplier Qualification Programme.&lt;/li&gt;
&lt;li&gt;Review Corrective and Preventive Actions (CAPAs), monitor their implementation and effectiveness, and support the overall CAPA Programme as part of continuous improvement.&lt;/li&gt;
&lt;li&gt;Support the external audit programme.&lt;/li&gt;
&lt;li&gt;Assist in the registration, follow-up, risk assessment and closure of change controls.&lt;/li&gt;
&lt;li&gt;Assist in the review of asset calibration and/or qualification documentation.&lt;/li&gt;
&lt;li&gt;Maintain and support the company&#039;s EOHS Management System, ensuring that relevant procedures, records and programmes remain current and effectively implemented.&lt;/li&gt;
&lt;li&gt;Coordinate and follow up on EOHS risk assessments, inspections, incidents, near misses and associated corrective/preventive actions.&lt;/li&gt;
&lt;li&gt;Support the implementation and monitoring of occupational health and safety, environmental, emergency preparedness and workplace safety programmes.&lt;/li&gt;
&lt;li&gt;Maintain applicable EOHS documentation, registers, records and training requirements and support compliance with applicable legislation and company standards.&lt;/li&gt;
&lt;li&gt;Participate in EOHS audits, inspections and continuous improvement initiatives, following up on identified actions through to closure.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Requirements&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Bachelor&#039;s degree or higher in Pharmacy, Life Sciences, or a related discipline.&lt;/li&gt;
&lt;li&gt;Minimum of 4 years&#039; experience in Quality Management within the pharmaceutical industry.&lt;/li&gt;
&lt;li&gt;Sound knowledge of EU cGMP and applicable local regulatory requirements.&lt;/li&gt;
&lt;li&gt;Knowledge or experience in Environment, Occupational Health &amp;amp; Safety (EOHS) systems would be considered an asset.&lt;/li&gt;
&lt;li&gt;Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.&lt;/li&gt;
&lt;li&gt;Strong organisational and problem-solving skills, with a high level of attention to detail.&lt;/li&gt;
&lt;li&gt;Ability to manage multiple priorities and follow actions through to completion.&lt;/li&gt;
&lt;li&gt;Must be in possession of a valid work permit.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;/p&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 and development opportunities.&lt;/li&gt;
&lt;li&gt;The opportunity to work in a state-of-the-art Testing and Batch Certification Facility within a dynamic pharmaceutical quality environment.&lt;/li&gt;
&lt;/ul&gt;

Senior Quality Assurance Officer (Quality Management Systems & EOHS)

&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;

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