We are currently looking for a Director Regulatory Affairs - Global Regulatory Lead to join a leading Biopharmaceutical company based in the Berkshire area. As the Global Regulatory Lead you will be responsible for a product portfolio and will manage all Regulatory activities related to this product at a Global level.
This is a Director level opportunity and would suit someone with knowledge and experience of Global regulatory procedures and legislation for Drug Development, Clinical Trail Submissions, Product Registration, Line Extension and License Maintenance.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Director Regulatory Affairs - Global Regulatory Lead will be varied however the key duties and responsibilities are as follows:
1. You will develop and implement Global Regulatory Strategy and ensure your product team reach regulatory milestones in a timely and compliant manor.
2. You will be accountable for the review of Global and Regional submissions across the full life cycle of a particular product portfolio.
3.You will be the main point of contact for Global Health Authority interactions as well as acting as point of contact for internal key stakeholders where you will supply strategic recommendations and risk assessment on key projects.
4. You will Lead a matrix team of Regulatory professionals and ensure all regulatory activities are carried out in a timely and compliant manor.
To be successful in your application to this exciting opportunity as the Director Regulatory Affairs - Global Regulatory Lead we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (e.g. Biology, Chemistry, Pharmaceutical Sciences, Regulatory Affairs) in addition to extensive Regulatory Affairs experience where you have knowledge and experience of Regulatory activities across the full life cycle of a product.
2. Proven industry experience of direct interactions and negotiations with health authorities, where Global experience will greatly benefit your application.
3. Have the ability to Lead, Delegate, Influence and Communicate to a high standard where you can project manage cross-functional teams and positively contribute to Global Regulatory Strategy.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves