We have announced recently that we are relocating all employees from Stockley Park to our headquarters, GSK House in Brentford, in Q2 and Q3 2020. We want to co-locate our teams and provide a modern fit-for-purpose working environment supporting GSK’s Modern Employer ambition. While these roles will be based initially at Stockley Park, they will move to GSK House during Q2 or Q3 2020. We also offer flexible working arrangements with respect to working from home.
We have a fantastic opportunity for a talented Global Regulatory Affairs Senior Director with extensive regulatory affairs knowledge/experience to join our Therapeutic Group in West London. This represents an exciting opportunity to be part of GlaxoSmithKline (GSK) Pharmaceutical Research & Development (R&D), who is committed to innovative scientific research and discovery to help people do more, feel better, live longer.
In this role, you will provide regulatory strategic leadership and support for our early and/or late stage Pharmaceutical R&D portfolio in the Specialty area. In Specialty, we are actively studying treatments for COVID-19, as well as a range of therapies for serious unmet needs in Respiratory, Rheumatology, GI, and Infectious Diseases.
Our Global Regulatory Affairs (GRA) Therapeutic Group in Pharmaceutical R&D develops global regulatory strategies to deliver our innovative portfolio. We are strategic partners with other functions in R&D and Commercial in delivering and maintaining our product pipeline, whilst complying with Health Authority regulations. We share learnings and best practices to foster continuous improvement. We strive to shape the evolving regulatory environment and influence policies/guidelines in areas that are key priorities for GSK.
We operate by fostering strong global teamwork and building trusting relationships with internal and external partners, including Regulatory Agencies. We use our leadership, strategic thinking, smart risk-taking skills, global regulatory acumen, analytical ability, communication and influencing skills to advise our internal partners and negotiate with external stakeholders.
We believe in life-long learning and developing our people. We take ownership of our development, as driven by on-the-job experiences, interactions with people, formal instruction and access to learning resources, with support from our leaders.
Key Responsibilities include, but are not limited to:
· Serving as an empowered Global Regulatory Lead and/or Regional Lead for assigned assets.
· Leading development of appropriate global and/or regional regulatory strategy and its execution consistent with the overall Medicines Development Strategy.
· Acting as a key strategic partner with the R&D and commercial teams and working closely with the broader regulatory matrix team to conceive and deliver innovative regulatory strategies for assigned assets
· Integrating aspects of strategic and operational regulatory affairs into asset development collaborating with the cross functional team including clinical research, biostatistics, nonclinical, CMC, diagnostics/device, etc.
· Leading preparations and delivery of regional Health Authority interactions, clinical trial applications and marketing authorizations with the cross functional development and regulatory team
· Proactively counsel teams and interpret health authority feedback, regulatory precedent, guidelines and policy to drive the product strategy, as well as driving or supporting efforts to shape the regulatory environment.
About You: To deliver in this role you will need to combine technical experience, as outlined below, with excellent communication skills, both written and verbal. You will have proven ability to deliver key communications with clarity, impact and passion. You will have proven negotiation skills and will be able to apply these across all levels within the organisation and with external stakeholders, including regulatory agencies. You will be a multi-tasker, who can balance multiple projects simultaneously and proactively plan your work, and the work of project teams, for the most successful results.
We are looking for professionals with these required skills to achieve our goals:
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses (Pharmaceuticals, Vaccines & Consumer Health) research and deliver innovative medicines, vaccines and consumer healthcare products. We are committed to overcoming some of the biggest challenges in global health; delivering products of value in a responsible, sustainable way; and providing access to medicine for the world's poorest communities.
In Pharmaceuticals, our approach to R&D focuses on science related to the immune system, and the use of genetics and investments in advanced technologies (view video to learn more about our strategy). We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Please don’t hesitate to contact us if you’d like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email email@example.com
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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Rbw Consulting Limited
From £80,000 to £90,000 per annum Bonus / Excellent …
London, South East
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