Regulatory Affairs Associate - Biotechnology Company

The successful Regulatory Affairs Associate will be responsible for coordinating with the Associate Director – Regulatory Affairs to provide support on the execution of regulatory strategy. The role will provide input to cross-functional teams where they represent Regulatory Affairs to ensure clinical studies are executed and completed in compliance with regional and local regulations and in alignment with regulatory commitments and study timelines. The role will contribute to the authoring and compilation of regulatory documents and submissions, as well as the review of regulatory processes and guidelines.

Responsibilities

• To work with the Associate Director of Regulatory Affairs and/or the Regulatory function in the execution of the regional and/or global regulatory strategy across all stages of product development depending on the program assigned.

• Coordinates and manages regulatory affairs-related clinical trial activities, including;

·        Preparation of initial IND/CTA submissions and maintenance through to study completion, including oversight of external CROs/consultants where appropriate

·        Regulatory strategy and timing of clinical study amendments

·        Interfacing with regulatory authorities, as appropriate, to facilitate approvals

·        Tracking, reporting and filing in electronic trial master files (eTMF) clinical trials management system (CTMS) or other applicable systems

·        Assists in preparing and reviewing clinical trial associated documentation (including IMPDs, IBs, EudraCT, protocols and labelling).

Qualifications  

·        Degree in Pharmacy, Medicine or Life Sciences, preferably with a PhD 

·        Basic understanding of the current UK and European regulations, laws, guidelines and industry requirements.

·        Ideally minimum of 1 year of Regulatory Affairs experience

·        Must be proficient in IT with strong knowledge of Excel, Word, PowerPoint, SharePoint.

For further information please get in touch with Natalie Jones via natalie@linkfieldgroup.com or call 02071835059