Global Regulatory Affairs Strategy Leader
3 weeks ago
Global Regulatory Affairs Strategy Leader
About 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 platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Estimated Salary:$180,000 - $220,000 per year
Job Description:Company Overview:
At 9627 Corixa Corporation, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade.
R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.
Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery.
We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.
Key Responsibilities:- Accountable to the asset GRL and/or the Global Regulatory TG Head for development and delivery of appropriate regulatory strategy(ies) according to plans.
- In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK up to VP level and representing GSK GRA in interactions with key regulatory agencies (EMA, CBER, PMDA etc).
- Work closely with R&D, Medical and Commercial teams to secure best possible labelling commensurate with the available data.
- 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.
- Bachelor's degree in biological or healthcare science.
- Five or more years of experience of all phases of the drug development process in regulatory affairs, including projects with little or no precedence.
- Three or more years of experience of leading regional development, submission and approval activities in local region(s).
We offer a comprehensive benefits program, including competitive salary, bonus structure, stock options, retirement savings plan, and more.
-
Pune, Maharashtra, India Philips Full timeJob OverviewWe are seeking a highly skilled Regulatory Affairs Leader to join our team at Philips.About the RoleThis is an exciting opportunity to lead our Regulatory Affairs function for medical devices, driving strategic growth and ensuring compliance with global regulations.Key ResponsibilitiesDevelop and implement regulatory strategies to bring...
-
Pune, Maharashtra, India 9627 Corixa Corporation Full timeJob SummaryThe 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:Accountable to the asset GRL and/or...
-
Global Regulatory Affairs Director
3 weeks ago
Pune, Maharashtra, India 9627 Corixa Corporation Full timeJob 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...
-
Global Regulatory Affairs Director
1 month ago
Pune, Maharashtra, India 9627 Corixa Corporation Full timeAt 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...
-
Regulatory Affairs Director IGTS-MoS
3 weeks ago
Pune, Maharashtra, India Philips Full timeJob 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...
-
Regulatory Affairs Director, IGTS-MoS
4 weeks ago
Pune, Maharashtra, India Philips Full timeJob 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...
-
Regulatory Affairs Director IGTS-MoS
4 weeks ago
Pune, Maharashtra, India Philips Full timeJob 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...
-
Regulatory Affairs Director for Vaccines
1 month ago
Pune, Maharashtra, India 9627 Corixa Corporation Full timeAre 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...
-
Regulatory Affairs Specialist
1 month ago
Pune, Maharashtra, India Avient Full timeJob 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...
-
Chemical Regulatory Affairs Specialist
4 weeks ago
Pune, Maharashtra, India Avient Full timeJob 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 9627 Corixa Corporation Full timeJob 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...
-
Regulatory Affairs Specialist
4 days ago
Pune, Maharashtra, India Lifelancer Full timeCompany OverviewLifelancer is a pioneering Clinical Research Organization (CRO) dedicated to advancing clinical trials in the Hospitals and Health Care industry. With its headquarters in Maharashtra, our team of 11-50 employees is committed to supporting cutting-edge healthcare solutions.Job SummaryWe are seeking an experienced Regulatory Affairs Trainee to...
-
Global Delivery Leader
1 month ago
Pune, Maharashtra, India Clarion Technologies Full timeGlobal Delivery LeaderAt Clarion Technologies, we are seeking a seasoned professional to lead our global delivery team. As a Global Delivery Leader, you will be responsible for overseeing the execution of our global delivery strategy, ensuring timely and high-quality delivery of projects to our clients.Key Responsibilities:Develop and implement global...
-
Strategic Leader for Global Payment Initiatives
4 weeks ago
Pune, Maharashtra, India BNY Full timeJob Title: Senior Vice President, POM Product ManagementAbout the RoleWe are seeking a seasoned leader to join our team as Senior Vice President, POM Product Management. This role will be responsible for leading the strategic direction, development, and execution of our global payment initiatives.Key ResponsibilitiesDevelop and execute a comprehensive...
-
Global Consolidation Leader
3 weeks ago
Pune, Maharashtra, India NielsenIQ Full timeJob Title: Global Consolidation LeaderWe are seeking an experienced Consolidation Leader to join our team at NielsenIQ. As a key member of our finance team, you will be responsible for leading our Group Consolidation activities, ensuring seamless execution of periodic services and maintaining the highest level of process accuracy.Key Responsibilities:Oversee...
-
Global Sourcing Leader
4 weeks ago
Pune, Maharashtra, India Gallagher Full timeGlobal Sourcing Manager Role OverviewWe are seeking a highly skilled Global Sourcing Manager to lead our team of talent acquisition professionals, including Senior Sourcers. In this pivotal role, you will manage the sourcing function, overseeing the development and execution of advanced sourcing strategies to meet our global talent needs.Key...
-
Global Marketing Director for Mobile Surgery
3 weeks ago
Pune, Maharashtra, India Philips Full timeAbout the Role:This is an exciting opportunity to lead the global marketing efforts for our Mobile Surgery business, a key area of focus for Philips. As the Global Marketing Director, you will be responsible for developing and executing a comprehensive marketing strategy that drives business growth and customer engagement.Key Responsibilities:Develop and...
-
Compliance Expert Leader
2 weeks ago
Pune, Maharashtra, India Practicology Full time**Job Title:** Compliance Expert Leader**Company Overview:** Practicology is seeking a seasoned professional to lead our compliance initiatives and shape the security posture of our organization.**Estimated Salary:** $120,000 - $180,000 per yearResponsibilities:We are looking for an experienced Compliance Expert Leader to develop and implement a robust...
-
AI Strategy Director
1 day ago
Pune, Maharashtra, India Rainclouds Global Solutions LLP Full time**Job Summary**Rainclouds Global Solutions LLP is seeking a highly skilled AI Strategy Director to lead our Artificial Intelligence initiatives and drive innovation in the field.**About Us**We are a dynamic and forward-thinking organization committed to harnessing the power of Artificial Intelligence to solve complex business...
-
Global Sales Enablement Leader
3 weeks ago
Pune, Maharashtra, India CAPCO Full timeAbout the RoleAs a Global Sales Enablement Leader at Capco, you will play a critical part in developing and implementing strategies that enable the effective organization, quality assurance, and utilization of sales/consulting collaterals on our Knowledge portal – MarketHub.Act as a key Knowledge Management SME across regionsExecute access requests for...