Regulatory Affairs Manager
1 month ago
Are you a seasoned regulatory affairs professional looking to drive strategy and shape integrated regulatory development across portfolios? This exciting opportunity at GSK could be the perfect fit for you.
About the Role:As a Regulatory Affairs Manager/Associate Director, you will be responsible for leading regulatory submissions, interactions, and strategy related to products within the US. You will drive the CMC strategy, coordinate the timely preparation of technical regulatory documents, and identify risks to the business associated with submission data and information packages.
Key Responsibilities:- Develop and implement CMC regulatory strategies to support product development and lifecycle maintenance.
- Lead and mentor cross-functional teams to ensure compliance with regulatory requirements.
- Collaborate with internal and external stakeholders to shape the regulatory environment and drive business growth.
- Provide strategic direction and data assessment to inform business decisions.
- Ensure all CMC regulatory aspects are in place to avoid clinical holds and ensure continuity of market supply.
- Bachelor's Degree in Life Sciences or associated discipline.
- Experience in drug development and manufacturing, with a focus on complex worldwide CMC regulatory requirements.
- Developing experience in major filing activities, such as MAA/NDA/BLA, significant manufacturing change, or key development interactions.
- PhD in Life Sciences or associated discipline.
- Significant experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of team leadership.
- Continued professional growth in global regulatory affairs, including communication of evolving/emerging trends and policies.
GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together. 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).
We are an equal opportunity employer and adhere to affirmative action principles. 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).
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