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Director, Global Regulatory Affairs, Vaccines Lead

1 month ago

Pune, Maharashtra, India 9627 Corixa Corporation Full time
Job Summary

We are seeking a highly skilled Director, Global Regulatory Affairs, Vaccines to lead our regulatory strategy for vaccine development and licensure. As a key member of our team, you will be responsible for ensuring compliance with regional regulatory requirements and delivering the best possible labelling commensurate with available data.

Key Responsibilities:
  • Develop and execute regulatory strategies for assigned US assets, across all stages of the product life cycle, consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP).
  • Work closely 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 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.
  • 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.
Basic Qualifications:
  • Bachelor's Degree in Biological or Healthcare Science, or related field.
  • 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, with a track record of successful relationships with one or more Health Authorities.
Preferred Qualifications:
  • Advanced degree in Biological or Healthcare Science, or related field.
  • Ten or more years of experience in Regulatory Affairs.
  • Extensive knowledge of clinical trial and licensing requirements in the region and ideally sound knowledge globally.
  • Extensive knowledge and experience interacting with regulatory agencies.
  • Ideal experience in procedural/registration US regulatory affairs, including as a US authorised agent, liaison with US FDA.
  • Knowledge in IND and BLA regulations and US regulations pertinent to product development and licensure/post-licensure.
  • Knowledge and experience in clinical and CMC regulatory affairs for pre-licensed and clinical RA for licensed biologic products or vaccines.
  • Scientific basis for development (clinical/CMC) ideally for vaccines/biologicals.

Please visit our website 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.

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will 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.

Important notice to Employment businesses/Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/agency and GSK. In the absence of such written authorization being obtained, any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.