Do you want to work for a scientifically driven organisation that provides services to accelerate drug, biologics and medical technology development? If you would like the opportunity to work for an organisation that has a huge global footprint, is employee centric providing the best training and has 5% growth within the Regulatory team then this may be the role for you…
We are looking for an customer-centric, driven, passionate individual to join a company who is growing their Regulatory Affairs team globally. The company is looking for a Senior Regulatory Affairs Manager to manage projects related and facilitate global regulatory submissions with a focus on ATMPs.
This is a permanent position, paying a competitive salary plus excellent benefits. You will be based in the company's site in London.
Reporting to the Regulatory Affairs Director your role will include:
Develop and review regulatory submission documents in support of clinical trials with a specific focus in providing Advanced Therapy Medicinal Products (ATMP)/ Genetically Modified Organisms (GMO) advice and dossier compilation;
Developing, tracking, compiling, and maintaining full regulatory applications including Paediatric Investigation Plans (PIPs), Orphan Designations, and Market Authorisation Applications (MAAs);
Maintaining timelines for full regulatory submissions;
Providing regulatory advice and guidance to Sponsors and other departments to ensure compliance with UK and European regulations and requirements;
Developing scientific and regulatory briefing documents for meetings with the EMA;
Interaction with EMA, MHRA, and other regulatory agencies;
Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.
Skills and Experience Required:
Bachelor's degree and demonstrated regulatory affairs experience;
Knowledge of Advanced Therapy Medicinal Products (ATMP)
Experience with EMA and other regulatory agencies is preferred;
Strong computer skills, project management skills, and a high attention to detail;
Must be a team player with a global regulatory mind-set;
Supervision of junior level staff may be requiredBenefits:
In addition to a generous basic salary, the company offers the following benefits package:
Full details will be provided upon screening, please note applications will only be accepted from individuals who are eligible to work in the EU and unfortunately sponsorship will not be provided for this role. This is a permanent role based in London and upon successful screening, you will be shortlisted and if interested contacted for an interview. Please note that during the current climate it can take up to two weeks to receive feedback
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