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Takeda Development Center Americas, Inc. is seeking a Manager, Regulatory Affairs
CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various...
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...products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced... ...of the position are to drive improvements in regulatory affairs processes, systems and infrastructure whilst supporting regulatory...
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Work from home
Night shift
2 days per week
1 day per week
...revolutionary way?
What if you could be the first hire in Regulatory Affairs with the opportunity to build a strategy and your team as we... ...; further global experience would be a plus.
* Experience managing external teams at CROs and driving execution against key deliverables...
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Shift work
3 days per week
...Your main tasks will be related to the regulatory aspects of the development or improvement of products, including the management and application of Design Controls and the... ...interacting not only with your Regulatory Affairs team colleagues but also with members of the...
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...registration of products while maintaining compliance with all regulatory requirements and commitments. Evaluates proposed regulations... ...company's interests.
At this level, the incumbent independently manages a major segment of the Company's regulatory effort and serves...
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Remote job
Contract work
Local area
Night shift
...Boston and key offices in Singapore and India.
The Senior Regulatory Affairs Specialist will support and carry out the regulatory... ...strategies and deliverables within the assigned project teams
* Managing compliance to the requirements established by applicable Regulatory...
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Work experience placement
Remote job
Shift work
...products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced... ..., please visit
Job Summary:
In this role as a Senior Regulatory Affairs Specialist at Convatec, you will be responsible for leading...
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Local area
Work from home
Worldwide
Night shift
...registration and renewal activities for IL-labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device...
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Worldwide
...Description
We're looking for an Associate Director of Regulatory Affairs , working in Pharmaceuticals and Medical Products... ...able to meet deadlines
Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects...
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Flexible hours
...Key Accountabilities (Digital Factory Products)Conceive of and Implement the Regulatory Strategy in collaboration with Cross-Functional (Solution Leaders, SBU Marketing, Medical Affairs, BU Regulatory and other) partners. Collaborate with Digital Sol Regulatory Affairs...
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...over $4B in value, and have helped over 5 million patients worldwide achieve better outcomes.
Position Summary:
The Regulatory Affairs Manager is responsible for developing and implementing strategies to ensure compliance with regulatory standards and requirements...
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Worldwide
...We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As Senior Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting...
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...in which human potential is no longer hindered by the burden of disease.
Description:
Reporting to the Sr. Director of Regulatory Affairs and Policy, this role will support and lead activities within the Regulatory group to advance development of the assets in Wave...
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Local area
Remote job
...patients worldwide. Join us in celebrating their commitment to excellence in healthcare solutions!
The Role
As the sole Regulatory Affairs Manager, you'll lead the charge in ensuring compliance with regulatory standards for our medical device products. Your role...
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Worldwide
2 days per week
...therapies to patients worldwide.
Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and... ...How you will contribute:
Lead planning, execution, and management of regulatory submissions for assigned vaccines in various phases...
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Minimum wage
Holiday work
Full time
Temporary work
Local area
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Worldwide
...The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products... ...inquiries from regulatory agencies with thorough submission management
* Support preparation for Health Authority CMC meetings...
Nova Biomedical is hiring a Regulatory Affairs Specialist (Level II or Senior Level) in our Waltham, MA facility (Hybrid) to focus on assuring... ...experience is preferred
~ Statistics and data base management proficiency preferred Certified Quality Auditor and RAC...
...Director, Regulatory Affairs
About the Company
Globally recognized biotechnology company
Industry
Biotechnology
Type
Privately... ...be responsible for developing global regulatory strategies, managing regulatory aspects, and providing line management expertise....
...studies, including vimseltinib and DCC-3116.
See here for more details on our portfolio.
Job Description
The Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. In this role, the Manager of...
Full time
Temporary work
Summer work
Summer holiday
Flexible hours
...Description
We're looking for an Associate Director Regulatory Affairs CMC , working in Pharmaceuticals and Medical Products industry... ...clinical development, registration, and product life cycle management
Manages timely regulatory submissions that involve CMC...