Candidates

Job title: (Senior) Regulatory Affairs Manager - EU Development Focus A global clinical research organisation with offices in Central London are looking to expand their regulatory team. These roles will provide full-service support for development phase products across a range of therapy areas. Responsibilities: Maintaining full regulatory applications including Paediatric Investigation Plans (PIPs), Orphan Designations and Market Authorisation Applications (MAAs) Develop and review of regulatory submission documents for Interaction with EMA, MHRA, and other regulatory agencies Developing scientific and regulatory documents for EU agency meetings. Providing regulatory advice and guidance to Sponsors and other cross functional departments to ensure compliance with UK and European regulations and requirements Requirements: Experience with EMA, MHRA and other EU regulatory agencies is preferred Experience within Paediatric Investigation Plans (PIPs), Orphan Designations, and Market Authorisation Applications (MAAs) is essential Bachelor's degree as a minimum. Experience at all stages within the product life cycle. Salary and benefits: Private Medical and Dental insurance Company matched pension Performance related bonus Competitive base salary To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk

details

Job title: Regulatory Affairs Change Team Leader - FTC A leading European Pharmaceutical business in Middlesex are seeking a Regulatory Affairs Change Team Leader to join on a Fixed Term Contract. This role will take oversight of the preparation and priotising of post approval regulatory activities across the global product portfolio. Responsibilities: Develop and deliver training to standardize the approach the Regulatory Affairs and Regulatory Service Providers take to project management Build the project management skills and abilities to successfully deliver all post approval Regulatory Affairs projects effectively and on time. Liaise with the Regulatory Affairs leadership team, Regulatory Affairs Managers, and other key stakeholders to build a culture of delivery and customer focus Work alongside the Regulatory Performance Analyst to understand company expectations and execute new KPI's in line with achieving business standards. Requirements: Extensive Regulatory Affairs experience within the Pharmaceutical industry Proven project management experience in the Pharmaceutical sector within a regulatory environment Excellent communication skills, ability to write and speak with influence Strong influencing and negotiation skills, ability to co-ordinate teams Autonomously Salary and benefits: A competitive salary and bonus are on offer with this role

details

Job title: Regulatory Services Manager - FTC A leading European Pharmaceutical business in Middlesex are seeking a Regulatory Service Manager to join on a Fixed Term Contract. This role will take oversight of both regulatory service providers and delivery teams to ensure effective post approval maintenance. Responsibilities: Manage and develop relationships with regulatory service providers ensuring effective collaboration and communication project management of regulatory activities with third party regulatory services to achieve product strategic goals Manage the integration of regulatory services for new products following launch and product acquisition Investigate with internal and external stakeholders to identify issues, reviewing and progressing to completion Provide strategic input as a key member of the Central Regulatory Affairs leadership team Requirements: A minimum of 4 years Regulatory Affairs experience within the Pharmaceutical industry Prior experience manging third party suppliers would be beneficial Excellent communication skills, ability to write and speak with influence Strong influencing and negotiation skills, ability to co-ordinate teams without direct authority Salary and benefits: A competitive salary and bonus are on offer with this role To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk

details

Job title: (Senior) Regulatory Affairs Manager - Rare Disease/Gene Therapy - Home Based A Rare Disease/Gene therapy business in the UK are seeking a Home Based (Senior) Regulator Affairs Manager. This role will focus on the UK/IE markets and the upcoming withdrawal from the EU markets. Alongside the maintenance of a recently launched product, this role will also support the launch of further products over the coming years. The ideal candidate will have experience within Rare Disease/Gene Therapy and a strong background in the UK/IE and EU markets. Responsibilities: Act as regulatory submission lead for high quality UK pre- and post-MA submissions in accordance with the Global and European regulatory strategy. Participate in regulatory intelligence activities; monitor and inform on regulatory guidelines and trends in Europe with a focus on the UK relationship with the European Union Drive the implementation of regulatory guidance in the UK after the end of the withdrawal agreement transition period. Lead the creation and maintenance of local regulatory deliverables, including creation of national prescribing information, review and approval of educational materials, reviewing local artwork, input and review of promotional and non-promotional materials. Prepare and review sections of regulatory submissions to optimise product development (e.g. Orphan Drug, Paediatric Investigation Plans, scientific advice etc.). Develop and maintain SOPs and work instructions (WIs) Requirements: Minimum 5 years of regulatory experience in a biotech or pharmaceutical company preferably including biologics/ATMPs In-depth knowledge of current regulations, guidelines - specifically UK/IE Experience in rare diseases and/or cell and gene therapies and/or innovative biologics products would be advantageous Prior experience in leading a Brexit readiness project would be ideal Salary and benefits: A highly competitive salary, annual bonus, healthcare, and pension are on offer To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk

details