ProClinical is happy to advertise an opportunity for a talented and hardworking individual to join a Regulatory Affairs Associate Director position at a leading global pharmaceutical company that focuses on therapeutics towards genetically defined targets for the treatment of serious, life-threatening diseases with limited treatment options. The Associate Director, Regulatory Affairs, join the UK team in Maidenhead.
This position will involve contributing to the development of regulatory strategy for specific projects, including identifying and assessing regulatory risks, and taking active involvement in the writing and reviewing of regulatory submissions. They will report to the VP, Regulatory Affairs.
Job Responsibilities:
- Providing strategic regulatory leadership to project teams.
- Leading the planning, preparation (including authoring where relevant), and delivering of both simple and complex submissions throughout the product's life cycle. This includes, but isn't limited to, clinical trial applications, paediatric investigation plans, briefing documents, and MAAs.
- Identifying potential regulatory risks to the strategic/operational plans and proposing options to mitigate risks.
- Leading negotiations with Regulatory Agencies.
- Leading the delivery of timely marketing approvals and advantageous product information in keeping with the needs identified by the business and in compliance with local market regulations.
- Defining innovative strategies to partner with Regulatory Agencies to increase the predictability of regulatory outcome and to provide the regulatory platform to support market access.
- Managing relationships with CROs and Regulatory Affairs consultancies to ensure business objectives are met.
- Providing regulatory due diligence assessments in cooperation with Business Development as required.
- Contributing to the preparation of new regulatory guidance and communicating the impact of new regulatory requirements across the organisation.
Skills and Requirements:
- A university degree in a Science discipline, or related. A higher degree would be more desirable.
- An extensive knowledge/experience of working in one or more areas in Regulatory Affairs in the pharmaceutical or related industry, or experience at a health authority.
- Ideally, a combined mix of large company best practices and smaller company adaptability and experience.
- Sound knowledge and experience in Regulatory Affairs, and associated requirements, along with pharmaceutical industry experience of clinical trial and drug development work; a track record of successful drug development through product approval in Europe.
- A thorough knowledge of the drug development process.
- Demonstrable experience in interfacing with Regulatory Authorities in Europe, and an excellent track record of building relationships with and influencing Regulatory Agencies.
- Excellent communication skills; both presentation (face-to-face and via web demos) and written.
- Strong problem solving, persuasion, and negotiation skills; being able to execute solutions/deliverables in a timely manner.
- An ability to establish rapport quickly, with a demanding and expert client base.
- Excellent written and oral English skills, with other European languages a bonus.
- A proven ability to focus and work with attention to detail, along with retaining critical information.
To Apply:
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 call Alex Czuprynski on +44 203 869 2329 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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