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Job title: Regulatory Affairs Senior Director A global pharmaceutical company with products in Neurology, Oncology and Rare Diseases are seeking a Regulatory Affairs Senior Director to join their team. This is a UK and Ireland affiliate role, leading several cross functional teams. This position will sit on the Affiliate leadership team and report directly into the UK and Ireland General Manager. Responsibilities: Leading strategy, tactics and implementation of all regulatory aspects for assigned products Ensure regional regulatory specificities and needs are incorporated into the global plans through collaboration with local and intercontinental Regulatory Affairs where available. Provide guidance to the team of experts to ensure full compliance of local & global regulations applicable to the UK & Ireland affiliate Ensure that the UK and Ireland Affiliate has a compliant and comprehensive pharmacovigilance and complaint system in place. Provide regulatory input into the integrated development plan. In collaboration with other research & development departments, define the optimal plan to reach the target product profile Requirements: Significant experience in the pharmaceutical industry, including minimum 10 years in Regulatory Affairs Proven ability to influence leaders helping them to understand a highly regulated environment. Proven ability to lead cross functional teams. Extensive experience in UK/IE markets would be desirable. Salary and benefits: A highly competitive salary and wider benefits scheme is on offer To apply for this position or hear further details then please contact Freddie Hill at Freddie.hill@pharma-partners.co.uk

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Job title: Associate Director, Regulatory Affairs A global biopharmaceutical company in Berkshire are seeking a Regulatory Affairs Project manager to join their growing team. This role will be responsible to lead the UK/IE regulatory affairs function in the post EU environment. The ideal candidate will have significant experience in the planning and execution of regulatory activities in UK/IE markets. Responsibilities: Lead and develop a small team of regulatory affairs professionals in the post-EU exit environment. Identify changes to both EU and UK regulatory legislation and guidance and implement any required changes to local processes. Deliver regulatory submissions, i.e. variations, marketing authorisation applications, renewals, education materials, PIP and orphan submissions, clinical trial applications. Develop and maintain an effective relationship with the MHRA and HPRA. Requirements: Extensive industry experience in regulatory affairs in the UK/IE environment. A deep understanding of the post-EU regulatory environment in the UK (GB & NI). Experience liaising with the MHRA/HPRA. Previous line management experience would be beneficial. Salary and benefits: A highly competitive salary and wider benefits scheme is on offer To apply for this position or hear further details then please contact Freddie Hill via Freddie.hill@pharma-partners.co.uk

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Job title: Regulatory and Quality Director UK and Ireland A global pharmaceutical company with products in Neurology, Oncology and Rare Diseases are seeking a Regulatory and Quality Director. This is a UK and Ireland affiliate role, leading several cross-functional teams. This position will sit on the Affiliate leadership team and report directly into the UK and Ireland General Manager. Responsibilities: Provide effective leadership and development to the Regulatory and Quality Management functions Provide guidance to the team of experts to ensure full compliance of local & global regulations applicable to the UK & Ireland affiliate Ensure a local Quality Management System (QMS) is in place in compliance with corporate requirements and national regulations. Ensure that the UK and Ireland Affiliate has a compliant and comprehensive regulatory system in place To take overall responsibility for RSQ budget allocation and control, instigating corrective measures as required. Requirements: At least 8 years work experience, involving direct experience and/or, significant knowledge of Regulatory and Quality Management Systems experience Previous experience with regulatory process management Previous experience in quality management systems and internal audit / external inspections Proven ability to lead a multidisciplinary team of experts Proven ability to influence leaders helping them to understand a highly regulated environment Extensive UK and Ireland Regulatory experience is a must Commercial acumen, Excellent verbal, written, analytical and interpersonal skills Salary and benefits: A highly competitive salary, annual bonus, private healthcare, and wider benefits are on offer. To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk

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Job title: Regulatory Affairs Manager A Pharmaceutical company in Berkshire are seeking a Regulatory Affairs Manager to join their team. This role will be responsible for providing regulatory strategy for new marketing authorizations as well as life cycle management for their current products. Responsibilities: Liaise with affiliate companies to ensure the submissions of Marketing Authorisation Applications in their designated markets can be successful. the preparation of registration files and submission of MAAs in line with Regulatory Act as point of contact for Regulatory agency interactions including the preparation of briefing packages and strategy for meetings. Create and maintain SOPs and Work Instructions for the Regulatory Requirements: Substantial experience within Regulatory affairs and Pharmaceutical industry. Significant post approval experience working with multiple products/projects. Proven experience in EU Regulatory Affairs within either a R&D or established products Experience across UK and EU markets would be beneficial. Salary and benefits: A highly competitive salary and wider benefits scheme is on offer. To apply for this position or hear further details then please contact Freddie Hill via Freddie.hill@pharma-partners.co.uk

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