Site Name: USA - Pennsylvania - Upper Providence Posted Date: Nov 18 2024 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together. As an Associate Director of Global Regulatory Affairs, you will ensure the development and execution of global and/or regional regulatory strategies for assigned assets. These strategies will be in alignment with the Medicines Development Strategy/Integrated Asset Plan, ensuring compliance with internal GSK processes and policy as well as appropriate regulatory requirements. The ultimate goal is to deliver the best possible labelling that meets the Medicine Profile, commensurate with the available data. You will engage in extensive matrix working within GSK up to the VP level and represent GSK with local regulatory agencies. In this role you will Be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head for the development of appropriate regional regulatory strategies and their delivery according to plans. Collaborate with the Early/Medicine Development Team (EDT/MDT) or GRL to ensure a robust regulatory strategy is in place to support the development program and meet the needs of key markets. Work closely with local/regional commercial teams to secure the best possible labelling commensurate with the available data. Lead interactions with local/regional regulatory authorities. Proactively develop regulatory strategies that meet the needs of the local region(s), while considering the needs of other regions globally. Implement regional strategies in support of global projects. Ensure compliance with global/regional requirements at all stages of the product life cycle. Why you? Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree in biological or healthcare science. Minimum 2 years of Regulatory Affairs experience including interaction with Regulatory bodies Proven ability to manage development, submission, and approval activities in different regions globally. Ability to develop necessary specialist knowledge for the product in a specific oncology disease area Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Advanced Scientific Degree (PhD, MD, PharmD). Knowledge of all phases of the drug development process in regulatory affairs. Capability to lead regional development, submission, and approval activities in local region(s). Knowledge of clinical trial and licensing requirements in all major countries in the region and, ideally, knowledge of other key Agency processes globally. Knowledge of relevant therapy area and the ability to further develop necessary specialist knowledge for the product or area of medicine. Creative regulatory problem-solving capabilities, balancing agency expectations and compliance The annual base salary for new hires in this position ranges from $147,900 to $200,100 taking into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. 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/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. 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