Global Regulatory Affairs Director

1 month ago


Pune, Maharashtra, India 9627 Corixa Corporation Full time
Job Title: Global Regulatory Affairs Director

At GSK, we are committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Our Regulatory Affairs team plays a critical role in ensuring the development and execution of regulatory strategies that meet the needs of our patients, customers, and stakeholders.

Key Responsibilities:
  • Develop and execute regulatory strategies for assigned assets, across all stages of product development, consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP).
  • Ensure compliance with internal GSK processes/policies and regional regulatory requirements to deliver the best possible labelling commensurate with available data.
  • Collaborate with R&D, Medical, and Commercial teams to secure best possible labelling commensurate with available data.
  • Liaise closely with other GRA teams, such as non-clinical, CMC, Labelling, and AdPromo, through the Regulatory Matrix Team (RMT).
  • Lead regulatory interactions and review processes in local regions, serving as the point of contact to CBER for assigned assets.
  • Ensure appropriate interaction with regional commercial teams in local regions.
  • Ensure compliance with regional requirements at all stages of product life, from early development to life cycle activities.
Requirements:
  • Bachelor's degree in biological or healthcare science.
  • Five or more years of experience in all phases of the drug development process in regulatory affairs, including projects with little or no precedence.
  • Three or more years of experience leading regional development, submission, and approval activities in local regions.
Preferred Qualifications:
  • MS or PhD in biological or healthcare science.
  • Proven capability to advocate scientifically sound approaches persuasively to senior leaders in GSK and at Health Authorities.
  • Capable of providing assessment of potential in-license vaccines.

GSK is an Equal Opportunity Employer and adheres 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, covered/protected veteran status, or any other federal, state, or local protected class.



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