Regulatory Affairs Director
A global biopharmaceutical company is advertising a vacancy for a Regulatory Affairs Director, based in their UK office. The organisation focuses on developing treatments in the fields of oncology, cardiovascular & metabolic disease (CVMD), and respiratory fields, as well as actively participating in the fields of autoimmunity, neuroscience, and infection. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide.
- Leading the development and implementation of the regional or global regulatory strategy for a product/group of products.
- Ensuring that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets, and patients; This includes a health authority engagement strategy and considerations of expedited regulatory programs.
- Leading a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling, and members of the submission and execution team.
- Delivering regulatory milestones on your team, including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations.
- Leading preparations of the regulatory strategy document and target product labeling.
- Providing team leadership and participating in coaching and performance feedback to members of your GRST.
- Initiating and delivering key regulatory documents and plans and leading the negotiations with health authorities.
- Leading the objective assessment of emerging data against aspirations and updating senior management on project risks/mitigation activities.
- Learning from your peers and engaging in peer learning sessions so that the medicines that the company develops incorporate the latest approaches in regulatory science.
- Embracing the concept of novel regulatory tools and technology.
- Ensuring appropriate planning and construction of the global dossier and core prescribing information led by the respective teams.
- Being accountable for product maintenance, supply and compliance activities associated with marketed brands.
- Partnering with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.
Skills and Requirements:
- An advanced degree in a science related field and/or other appropriate knowledge/experience.
- At least 5-year experience of regulatory drug development or equivalent, and experience with major Health Authority interactions.
- Prior experience with phase 3 design including end of phase 2 health authority interactions is desired.
- Contribution to a regulatory approval including leading response team and labeling negotiations would be a plus.
- A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.
- A good understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.
- Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
- Experience in relevant therapy area (small molecules & biologics) is preferred.
- Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical components.
- Experience of EU procedures (MAA, variations, PIP, ODD).
- Experience working with EMA and national EU agencies.
- Experience of oncology and immuno-oncology would be great, but not essential.
- Experience of being global regulatory lead on early projects would be great.
- 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 Peter Duvall at +44 203 078 9542 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.
Up to £95000.00 per annum
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