Global Regulatory Affairs Leader, Vaccines and Infectious Diseases

3 weeks ago


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

The Director, Global Regulatory Affairs, Vaccines will be responsible for developing and executing the appropriate Regulatory strategy(ies) for assigned US asset(s), across all stages of the product life cycle and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP).

Key Responsibilities:
  1. Accountable to the asset GRL and/or the Global Regulatory TG Head for development and delivery of appropriate regulatory strategy(ies) according to plans.
  2. Ensure and drive the regulatory strategy that will deliver the needs of the assigned US region, taking into account the needs of other regions globally.
  3. Liaise closely with other GRA teams such as non-clinical, CMC, Labelling, and AdPromo through the Regulatory Matrix Team (RMT).
  4. Lead regulatory interactions and the review processes in local region e.g. be the point of contact for the assigned asset(s).
  5. Ensure appropriate interaction with regional commercial teams in local region.
  6. Ensure compliance with regional requirements at all stages of product life from early development to life cycle activities.
Requirements:
  1. Bachelor's Degree in Biological or Healthcare Science, or related field.
  2. Five or more years of experience of all phases of the drug development process in regulatory affairs, including projects with little or no precedence.
  3. Three or more years of experience of leading regional development, submission, and approval activities in local region(s).


  • Pune, Maharashtra, India 9627 Corixa Corporation Full time

    Job Title: Global Regulatory Affairs Strategy LeaderAbout 9627 Corixa CorporationWe are 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...


  • Pune, Maharashtra, India 9627 Corixa Corporation Full time

    Job SummaryWe 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...


  • Pune, Maharashtra, India 9627 Corixa Corporation Full time

    Are you looking for a challenging role in regulatory leadership where you can build advocacy and accelerate product development and licensure on a global scale, with a focus on the US? If so, this Director, Global Regulatory Affairs, Vaccines position could be an exciting opportunity to explore.As a Director, Regulatory Affairs, Vaccines, you will be...


  • Pune, Maharashtra, India 9627 Corixa Corporation Full time

    Are you looking for a challenging role where you can build a strong regulatory strategy and accelerate product development and licensure on a global scale, with a focus on the US? If so, this Director, Global Regulatory Affairs, Vaccines position could be an exciting opportunity to explore.As a Director, Regulatory Affairs, Vaccines, you will be responsible...


  • Pune, Maharashtra, India 9627 Corixa Corporation Full time

    At 9627 Corixa Corporation, we strive to positively impact the health of millions of people worldwide. Our R&D team is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. We are revolutionising the way we do R&D, uniting science, technology, and talent to get ahead of disease...


  • Pune, Maharashtra, India 9627 Corixa Corporation Full time

    At 9627 Corixa Corporation, we're committed to making a positive impact on the health of millions of people worldwide. Our team is dedicated to discovering and delivering innovative vaccines and medicines to prevent and treat diseases.Job Purpose:We're seeking a highly skilled Global Regulatory Affairs Director to join our team. As a key member of our...


  • Pune, Maharashtra, India 9627 Corixa Corporation Full time

    Job Title: Global Regulatory Affairs DirectorAt 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...


  • Pune, Maharashtra, India 9627 Corixa Corporation Full time

    Job Purpose: Ensure the development and execution of the appropriate Regulatory strategy(ies) for assigned asset(s), across all stages of the product development and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP). This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance...


  • Pune, Maharashtra, India Philips Full time

    Job Title: Director Regulatory Affairs IGTS-MoSJob Description:Director Regulatory Affairs IGTS-MoSCritical RA leader of the IGTS MoS Category (Image Guided Therapy Systems Mobile Surgery). Also, a member IGTS MoS Leadership Team and advise senior management on matters concerning several functional areas and/or customers.Your role:As the Head of Regulatory...


  • Pune, Maharashtra, India Philips Full time

    Job Title: Director Regulatory Affairs IGTS-MoSJob Description:The Director of Regulatory Affairs IGTS-MoS will be responsible for leading the regulatory affairs team in the development and implementation of regulatory strategies for the Image Guided Therapy Systems Mobile Surgery category. This includes ensuring compliance with relevant regulations,...


  • Pune, Maharashtra, India 9627 Corixa Corporation Full time

    Job SummaryWe are seeking a highly skilled Senior Manager, CMC Facilities Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for our manufacturing facilities and equipment.Key Responsibilities:Develop and implement regulatory strategies for CMC...


  • Pune, Maharashtra, India Philips Full time

    Job Title: Director Regulatory Affairs IGTS-MoSJob Description: Director Regulatory Affairs IGTS-MoS:Critical RA leader of the IGTS MoS Category (Image Guided Therapy Systems Mobile Surgery) with a strong background in formulating global strategies to ensure compliance with worldwide regulations.As the Head of Regulatory Affairs for the IGTS MoS team, you...


  • Pune, Maharashtra, India Avient Full time

    Job SummaryThe Regulatory Specialist plays a crucial role in the Product Stewardship team, responsible for managing all regulatory matters for the global business. This involves liaising with global company locations and customers in various regions, including Europe, Asia, North America, and Latin America.Key Responsibilities:• Develop and implement...


  • Pune, Maharashtra, India Avient Full time

    Job SummaryThe Regulatory Affairs Specialist will support the Product Stewardship team in managing global regulatory matters, collaborating with internal and external partners, and ensuring compliance with chemical legislation. The role involves developing and implementing regulatory information systems, providing training and support to the team, and...


  • Pune, Maharashtra, India Philips Full time

    Job TitleDirector Regulatory Affairs IGTS-MoSJob DescriptionRegulatory Affairs Director for IGTS-MoSCritical RA leader of the IGTS MoS Category (Image Guided Therapy Systems Mobile Surgery) is sought for a rewarding opportunity to utilize Regulatory Affairs/Compliance expertise and critical leadership abilities in leading the Image Guided Therapy MoS...


  • Pune, Maharashtra, India 12371 GSK Vaccines S.r.l. Full time

    Job SummaryThe Executive Director, Safety Evaluation & Risk Management (SERM) Head is accountable for leading the SERM medical and scientific staff and defining the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies.Key ResponsibilitiesTranslate strategic plans into operational plans,...


  • Pune, Maharashtra, India Philips Full time

    Job Title: Director Regulatory Affairs IGTS-MoSJob Description:Detailed Role:Lead the Global Image Guided Therapy MoS Regulatory Affairs team, driving innovation and delivering high-quality regulatory affairs input and deliverables for new product introductions and product changes worldwide.Collaborate with cross-functional category leadership teams to...


  • Pune, Maharashtra, India Philips Full time

    Job Title: Regulatory Affairs Director for Image Guided Therapy SystemsJob Description:Regulatory Affairs Director for Image Guided Therapy SystemsCritical RA leader of the IGTS MoS Category (Image Guided Therapy Systems Mobile Surgery). Also, a member IGTS MoS Leadership Team and advise senior management on matters concerning several functional areas and/or...


  • Pune, Maharashtra, India Pharmabharat Full time

    Company OverviewPharmabharat is a Clinical Research Organization (CRO) dedicated to advancing clinical trials in the healthcare industry. With its headquarters in Maharashtra, our team of 11-50 employees is committed to supporting innovative healthcare solutions.Job OverviewWe are seeking a highly motivated Regulatory Affairs Trainee to join our team. This...


  • Pune, Maharashtra, India Pharmabharat Full time

    Company OverviewPharmabharat is a Clinical Research Organization (CRO) dedicated to advancing clinical trials in the healthcare industry. With its headquarters in Maharashtra, our team of 11-50 employees is committed to supporting innovative healthcare solutions.Job OverviewWe are seeking a highly skilled Regulatory Affairs Trainee to support our team in...