Manager, Global Regulatory Affairs

Site Name: USA - Massachusetts - WalthamPosted Date: Aug 30 2024Accountable to GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans.In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency.Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities.Key Responsibilities:• Proactively develop regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally.• Implement the regional strategy(s) in support of the project globally• Lead regulatory interactions and the review processes in local region• Ensure appropriate interaction with global/regional counterparts and commercial teams in local region• Ensure compliance with global/ regional requirements at all stages of product life• Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset.Basic Qualifications:• BSc in Biological or Healthcare Science• Experience of all phases of the drug development process in regulatory affairs preferred• Experience with clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally.• Experience in relevant therapy area, and ability to further develop necessary specialist knowledge for the product or area of medicinePreferred Qualifications:• PhD in Biological or Healthcare Science• Capable of leading regional development, submission and approval activities in local region(s)• Ability to foster strong matrix working. Facilitates dialogue between team and matrix members to contribute their ideas. Capable of developing and recommending strategies for change.• Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Seeks to raise levels of performance by establishing or improving process• Good communication skills, especially in writing. Capable of delivering key communications with clarity, impact and passion• Ideally good listening and comprehension skills; proactive in identifying potential issues and escalating them accordingly• Capable of identifying project or team issues in advance and seeking necessary help and support to resolve.• Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Recognises potential long term issues for projects.• Ability to take sound decisions and in doing so, the job holder will use a range of sources and weight benefits and risks before making important decisions.• Developing personal networks, within GSK and capable of using them to secure appropriate support and outcome for a project.Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.