Director, Global Regulatory Affairs, Precision Medicine
vor 2 Monaten
We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at 1925 GlaxoSmithKline LLC. As a key member of our organization, you will play a critical role in ensuring the development and execution of appropriate regulatory strategies for our precision medicine and digital health assets.
Key Responsibilities- Develop and execute global regulatory strategies for precision medicine and digital health assets, ensuring compliance with internal GSK processes and policies, as well as regional regulatory requirements.
- Lead or participate in interactions with local and regional regulatory authorities, representing GSK's interests and ensuring the best possible labeling for our products.
- Collaborate with cross-functional teams, including Experimental Medicine Unit and Digital Health teams, to ensure seamless execution of regulatory strategies.
- Ensure compliance with regulatory requirements at all stages of product life, from C2MD to commercialization.
- Advocate for regulatory approaches to senior leaders within GSK and health authorities, leveraging your expertise to drive business decisions.
- Master's degree in biological science, healthcare science, or engineering.
- Experience in regulating companion diagnostics and SaMD, with a proven track record of leading global development, submission, and approval activities.
- Strong understanding of clinical trial and licensing requirements for precision medicine and digital health products in major countries.
- Excellent communication and interpersonal skills, with the ability to facilitate matrix working and lead change initiatives.
- Proven ability to build strong personal networks and derive creative solutions to regulatory problems.
At 1925 GlaxoSmithKline LLC, we are committed to uniting science, technology, and talent to get ahead of disease together. We are a global biopharma company with a special purpose – to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns. We prevent and treat disease with vaccines, specialty, and general medicines, focusing on four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology.
We are an equal opportunity employer and adhere to affirmative action principles, ensuring that all qualified applicants 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, or any other protected class.
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Zug, Zug, Schweiz 1925 GlaxoSmithKline LLC VollzeitPurposeDevelop and execute a comprehensive regulatory strategy for Precision Medicine and Digital Health assets across the GSK therapeutic portfolio, ensuring compliance with internal processes and regional regulatory requirements.Responsibilities and AccountabilitiesLead the development of global regulatory strategies for Precision Medicine and Digital...
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