CMC Regulatory Strategy Director
5 days ago
This is an exciting opportunity to join our team as a Manager, Global Regulatory Affairs CMC in Cambridge, MA.
About the RoleThe successful candidate will be responsible for developing and implementing regulatory strategies for commercial and development phase products.
- Developing regulatory submission strategies for products in commercial and development phases by working in close coordination with the quality, manufacturing, and global regulatory teams;
- Ensuring timely responses to health authority queries by working with regulatory teams across different regions;
- Submitting compliance submissions such as annual reports, yearly biologic periodic reports, and license renewals in a timely manner to ensure marketed products comply with Health Authority requirements;
- Providing regulatory assessments for change controls for various markets, including US FDA, EMA, and Health Canada, as well as liaising with in-country regulatory representatives to provide these assessments.
Takeda Development Center Americas, Inc. is a leading pharmaceutical company that offers a dynamic work environment with opportunities for growth and development.
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Global Regulatory Specialist Leader
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Dubai, Dubai, United Arab Emirates ClickJobs Full timeRegulatory Affairs Manager Job OpportunityWe are seeking an experienced professional to lead our Global Regulatory Affairs CMC Team in Cambridge, MA.Key ResponsibilitiesDeveloping and executing regulatory strategies for commercial and development phase products;Collaborating with cross-functional teams to ensure compliance with Health Authority...
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Dubai, Dubai, United Arab Emirates ClickJobs Full timeJob DescriptionTakeda Development Center Americas, Inc. is seeking a skilled professional to join our team as a Manager, Global Regulatory Affairs CMC in Cambridge, MA.About the RoleThis exciting opportunity involves developing and implementing regulatory strategies for commercial and development phase products in close collaboration with quality,...
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Dubai, Dubai, United Arab Emirates ClickJobs Full timeJob DescriptionTakeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements:Master's degree in Regulatory Affairs or related field plus 2 years of related experience.Prior experience must include:Developing the regulatory submission strategies for products in commercial and...
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Dubai, Dubai, United Arab Emirates ClickJobs Full timeJobDescriptionTakeda DevelopmentCenter Americas, Inc. is seeking a Manager, Global RegulatoryAffairs CMC in Cambridge, MA with the following requirements:Master's degree in Regulatory Affairs or related fieldplus 2 years of related experience. Prior experience must include:Develop the regulatory submission strategies for products incommercial and development...
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Dubai, Dubai, United Arab Emirates ClickJobs Full timeJobDescriptionTakeda DevelopmentCenter Americas, Inc. is seeking a Manager, Global RegulatoryAffairs CMC in Cambridge, MA with the following requirements:Master's degree in Regulatory Affairs or related fieldplus 2 years of related experience. Prior experience must include:Develop the regulatory submission strategies for products incommercial and development...
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