Regulatory Affairs Director
4 weeks ago
At GSK, we are seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing regional regulatory strategies to ensure compliance with internal GSK processes and regional regulatory requirements.
Key Responsibilities:
- Develop and execute regional regulatory strategies to support the development of pharmaceutical products.
- Collaborate with cross-functional teams to ensure regulatory compliance and effective communication with health authorities.
- Lead interactions with local and regional regulatory authorities to ensure compliance with regulatory requirements.
- Work closely with commercial teams to secure best possible labeling commensurate with available data.
- Ensure compliance with regional requirements at all stages of product life cycle.
Requirements:
- Bachelor's degree in a relevant field.
- Experience in Regulatory Affairs within a pharmaceutical organization.
- Experience working with Global Health Authorities and submissions for pharmaceutical products.
Why GSK?
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 believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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.*
*US only.
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