Site Name: USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence Posted Date: Dec 17 2024 Are you looking for a highly visible regulatory leadership role where you can build advocacy and accelerate regulatory compliance on an international scale? If so, this Regulatory Affairs Management Director role could be an exciting opportunity to explore. As a Director, Global Regulatory Affairs, Vaccines you will be responsible for leading regulatory strategy, operations, quality and risk management functions across international markets. Key Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Establish strategic direction for all regulatory processes in regional countries (Cluster) in alignment with regional Regulatory Affairs objectives and Cluster functions (Commercial, Medical etc). Lead regulatory governance in Cluster. Ensure local responsibilities relating to regulatory conformance (local regulations, corporate policies and procedures) are adhered to. Lead the appropriate maintenance of records by the development and implementation of effective procedures to ensure that all regulatory processes and information are traceable and aligned with local regulations, corporate policies and procedures. Ensure an effective regulatory internal control framework is in place including appropriate processes and associated training to ensure the staff are compliant with regulatory and associated legal requirements. Ensure implementation of the processes and tracking of relevant metrics as defined by the Regional Regulatory Affairs Key Performance Indicators (KPIs). Facilitate the strategic development and deployment of regulatory projects through prioritization, allocation of resources and enabling communication across functions within Local Operating Countries (LOCs), at the cluster and area levels. Ensure effective recruitment and personal and professional development of the staff through a coordinated, well managed, strategically aligned program. Accountable for LOC regulatory objectives including resource allocation and budgeting process for regulatory activities. Enable and participate in the continuous dialogue, co-operation and planned resolution of major issues of concern with key regulators and other health authorities. Ensure appropriate advocacy strategies are in place to shape evolving legislation / requirements in partnership with relevant experts. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree 5 or more years industry regulatory affairs experience 5 or more years leading matrixed teams across global regions Preferred Qualifications: If you have the following characteristics, it would be a plus: PhD or Masters’ degree in life sciences or pharmacy Strong technical knowledge required to be able to assess regulatory compliance of products Ability to interact with regulatory officials and support advocacy initiatives #LI-GSK The annual base salary for new hires in this position ranges from $184,195 to $249,205 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. 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