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Regulatory Affairs Specialist - Pharmaceutical Development job in Chertsey at Atom Recruitment Ltd

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Regulatory Affairs Specialist - Pharmaceutical Development at Atom Recruitment Ltd

Regulatory Affairs Specialist - Pharmaceutical Development

Atom Recruitment Ltd Chertsey, Surrey Full Time
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Our Client develops and distributes licensed and unlicensed medicinal products. They use proprietary drug delivery technologies to reformulate existing medicines, to create bespoke products to address the unmet medical needs of patients with niche diseases. The strategic intent of our client is to develop and register more products as licensed medicines, applying for Marketing Authorisation’s whenever commercially justified.

Our Client uses trusted contract development and manufacturing partners to produce their medicines, which they distribute in the UK and overseas via distribution partners. They are committed to the highest quality standards in their business, and to operating within the Medicines and Healthcare products Regulatory Agency (MHRA) regulatory framework especially to ensure compliance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP).

They are now seeking a Regulatory Affairs Specialist. This position is a full-time permanent role and will report to the Regulatory Affairs Manager. The position will be office based in Surrey with occasional travel.

Purpose of Job

Take responsibility for managing regulatory aspects of product development projects intended for inclusion into Marketing Authorisation Applications and lifecycle management of approved Marketing Authorisations. This includes preparing and maintaining dossier documentation, CMC documentation, licence variations and product information in the UK, Europe or globally.

Key Areas of Responsibility

Develop the technical quality data, non-clinical and clinical data of selected product to eCTD standard to support MAA:

* Identify the weaknesses and gaps in the quality areas of the developed drug products, this may include the drug substance, drug product, non-clinical and clinical areas of the selected products

* Take responsibility for preparing and maintaining dossier and CMC documentation

* Manage the life-cycle of products in the licenced territories (UK, Australia and Europe)

* Prepare and review CMC documentation for Modules 1, 2 and 3

* Prepare and submit new Marketing Authorisation Applications (MAAs)

* Provide expert strategy advice on regulatory pathways, which may be complex

* Liaise with regulatory groups, manufacturing facilities and external contractors to ensure the relevant documentation is available

Manage regulatory aspects of product development projects for licenced products:

* Work in collaboration with internal stakeholders to identify and design regulatory and technically viable product development opportunities for subsequent licence applications

* Identify and recommend the most appropriate regulatory strategy for each project

* Working with the Product Development team to identify the appropriate regulatory resources (financial, expertise) required for each project and ensure that these are allocated within the Company and the contract development, manufacturing and regulatory partner

* Report on project progress, advising stakeholders of challenges in a timely manner

Complete Company documentation in a timely and accurate manner:

* Ensure primary documentation at the external partner companies is prepared and signed off in advance of a decision being implemented

* Accurately document agreed activities with a clear audit trail

* Complete QMS and financial management documentation in a timely manner

* Prepare and send purchase orders in advance of work being undertaken by contract manufacturers and suppliers


* Work within the Company procedures and processes

* To keep up to date with regulatory and industry standards and apply to current projects

* Travel to and spend time as required at supplier, contract manufacturer or other potential partner sites

Qualifications / Experience

* BSc or equivalent science-based degree

* Prior experience of a Regulatory Affairs role, ideally with MAA experience and life-cycle management

* Ability to prepare, review and maintain product information and CMC documentation

* Experience of product development and new applications

* In depth understanding of the different application routes

* Post marketing experience including variations, renewals and labelling

* Experience developing and implementing regulatory strategies

* Preferably experience in writing / reviewing of IMPD’s/MAA’s

* Ability to establish and maintain effective working relationships with internal and external stakeholders

* Strong written and verbal communication skills

In return our client is offering a basic salary of c£45,000 per annum basic (salary is negotiable dependant on experience) plus benefits for the successful Candidate

Please send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd


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Job ID: 214748312


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