Manager / Associate Director - Global Regulatory Affairs

GlaxoSmithKline ,
Brentford, Greater London
More Details

Overview

Job Description

video 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 Associate Director/ Manager with strong 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 strategicsupport forourearly 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. Therapeutic Group, Global Regulatory Affairs 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: * Supporting the development of appropriate regional strategy and its execution consistent with the overall Medicines Development Strategy. * Acting as a key partner with the R&D and commercial teams and working closely with the broader regulatory matrix team to help 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/supporting 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 help drive the product strategy, as well as supporting efforts to shape the regulatory environment. Why you? To deliver in this role you will need to combine technical experience, as outlined below, with strong communication skills, both written and verbal. You will be capable of delivering key communications with clarity, impact and passion. You will have strong 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. Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: * Bachelors or advanced degree in appropriate scientific or clinical discipline * Capable of leading regional development, submission and approval activities in local regions, including leading some local health authority interactions * Knowledge of clinical trial and marketing authorization in all major countries in the region and ideally knowledge of other key Agency processes globally. * Demonstrated ability to think strategically and integrate regulatory science with scientific/clinical knowledge. * Demonstrated ability to foster strong matrix team working in a global team environment Preferred Qualifications: If you have the following characteristics, it would be a plus: * Master's Degree or PhD (or equivalent) * Global regulatory experience * Experience of all phases of the drug development process in regulatory affairs

People also viewed