Candidates

Job title: Senior Regulatory Affairs Manager EU A global Pharmaceutical company with offices North of London are seeking a Senior Regulatory Affairs Manager to assist in an upcoming product launch. This role will primarily focus on Pre Approval activities within the EU. Responsibilities: Development and maintenance of regulatory submissions/activities for products within the Migraine/Pain therapy area Lead external conversation with stakeholders withing the EU regulatory environment Develop and communicate regulatory strategies for internal stakeholders Review of submissions dossiers, submissions documents and development of product information. Requirements: Several years' experience within speciality pharmaceutical regulatory affairs Extensive experience of EU Pre Approval activities is essential Advanced understanding of global R&D process Experience of Post Approval regulatory activities is also essential Salary and benefits: A competitive salary, annual bonus, car allowance and other 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 EU - Established Products A global pharmaceutical business in Berkshire are seeking an experienced regulatory affairs professional to focus on post approval activities whilst supporting future launches over the coming years. Responsibilities: Deliver regulatory strategies & typical regulatory activities for marketed products of various therapy areas Lead cross-functional relationships with various departments such as commercial, with a focus on anticipating and mitigating regulatory risks Participate and contribute towards EU agency meetings and tasks Implement local affiliate regulatory strategy plans in accordance with EU Strategy Requirements: Minimum of 5 years' experience within Regulatory Affairs (Ideally Pharma) EU markets experience is essential Ability to work with various cross functional teams and departments Strong project management skills Salary and benefits: A competitive annual salary, long term incentives, car allowance, bonus and private healthcare 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: Responsible Person A small but growing life sciences business in Berkshire are seeking a Responsible Person. This role will be responsible for the safeguarding of patients from potential hazards arising from poor distribution practices. Responsibilities: Ensure that the conditions of the wholesale dealer's license are met, and the guidelines of Good Distribution Practice are complied with. To check ALL goods received are not counterfeit medicines, by looking for evidence of tampering or anything suspicious. To become familiar with eQMS system and keeping it updated Liaise with the MHRA and Home office as and when necessary. To be present for any visits by the MHRA and/or Home Office. To oversee audit of the quality system and to carry out independent audits. (Experience in hosting supplier/ client audits and regulatory audits such as MHRA). Requirements: Minimum of 5 years RP experience Solid experience of both internal and client auditing Understanding of comparator products Good Understanding of the Wholesale Dealer's Licence. Understanding of Directive 2001/83/EC Salary and benefits: A competitive salary and annual bonus 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: Senior Regulatory Affairs Officer A global Pharmaceutical business in Berkshire are seeking a Senior Regulatory Affairs Officer. In this role you will maintain marketing applications, develop submission strategies and gain marketing authorisations for new countries. Working in a small team you will report directly into the Senior Regulatory Affairs Manager - giving you great opportunity to learn and develop your career within Regulatory Affairs. Responsibilities: Prepare, submit and coordinate national Marketing Authorisation Applications Gain marketing authorisations for pharmaceutical products in new countries Compile regulatory documents in eCTD format Develop submission strategies for all CMC and safety changes Development and maintenance of regulatory Standard Operating Procedures Requirements: Experience dealing with multiple health authorities Degree in life sciences Experience submitting new MAAs Previous experience maintaining existing marketing authorisations Salary and benefits: A competitive salary, annual bonus and private medical insurance 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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