Regulatory Affairs Senior Manager
A renowned biotechnology company is advertising a vacancy for a Regulatory Affairs Senior Manager in the UK. The organisation focuses on facilitating the translation of great science into medicinal products that benefit patients. This is an exciting opportunity to work with a dynamic and innovative company that provides a great deal of flexibility to its teams, allowing for up to four days of working from home.
- Provide strategic regulatory advice to clients, taking regulatory guidelines into account, along with available measure to facilitate regulatory input, incentives and early market access (Including gap analyses, advice on filing routes, timings, regulatory authority interactions, paediatric development, orphan drug designation, and PRIME/Breakthrough Therapy Designation [BTD] applications).
- Preparing regulatory submission documents, including orphan drug designation applications, scientific advice briefing documents, clinical trial applications, and investigational new drug applications, paediatric investigation plans, PRIME/BTD, and marketing authorisation applications).
- Leading regulatory agency interactions/negotiations to ensure client goals are met.
- Providing support to all ongoing projects and business activities as required, including mentoring other members of the team as appropriate.
- Maintaining up to date regulatory knowledge and contribute to the company's regulatory intelligence function.
Skills and Requirements:
- At least a B.Sc. in a life sciences subject (a higher degree would be a distinct advantage).
- At least 5 years of experience gained in a consultancy environment.
- Proven capability in developing effective, timely, and tailored regulatory strategies across a range of products and therapeutic areas.
- Knowledge of the evolving regulatory environment, including proposed changed to legislation that may impact on the company's business and clients.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Alex Czuprynski at +44 203 869 2329 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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