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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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...#ForeverCaring and you will do the same.
Job Summary:
The primary responsibilities of the position are to drive improvements in regulatory affairs processes, systems and infrastructure whilst supporting regulatory strategy and registration across global markets across the...
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Work from home
Night shift
2 days per week
1 day per week
...medicines to patients through looking at and treating disease in a 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 expand our clinical pipeline?
What this position is all about:...
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Shift work
3 days per week
Responsibilities:
Your main tasks will be related to the regulatory aspects of the development or improvement of products, including... ...s such, you will be interacting not only with your Regulatory Affairs team colleagues but also with members of the R&D, Marketing, and...
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...and procedures, to ensure the rapid and successful development and registration of products while maintaining compliance with all regulatory requirements and commitments. Evaluates proposed regulations and advises on impact of such regulations on the company; may...
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Remote job
Contract work
Local area
Night shift
...participation on design and risk management teams, initiation of regulatory plans for both new products and significant product... ...documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/advertising...
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Worldwide
...constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit
Job Summary:
In this role as a Senior Regulatory Affairs Specialist at Convatec, you will be responsible for leading regulatory strategy and driving registrations across...
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Local area
Work from home
Worldwide
Night shift
...technology company enabling care delivery, with headquarters in Boston and key offices in Singapore and India.
The Senior Regulatory Affairs Specialist will support and carry out the regulatory strategy and other regulatory aspects of product development and processes...
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Work experience placement
Remote job
Shift work
...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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...products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant prod Regulatory Affairs, Regulatory, Specialist, Senior, Registration, Project Management, Manufacturing, Business...
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...disease.
Description:
Reporting to the Sr. Director of Regulatory Affairs and Policy, this role will support and lead activities within... ...ensure compliance with current regulatory requirements
Assist with regulatory agency inspections; monitor external consultants...
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Local area
Remote job
...have you in front of a live recruiter.
The Opportunity
Description
We're looking for an Associate Director of Regulatory Affairs , working in Pharmaceuticals and Medical Products industry in Cambridge, Massachusetts, United States .
Works...
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Flexible hours
...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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...boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in...
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Minimum wage
Holiday work
Full time
Temporary work
Local area
Remote job
Worldwide
...The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products. This position will oversee CMC Health Authority submissions, collaborating across the business and with external partners to...
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...leadership team is seeking a highly motivated and experienced VP of Regulatory Affairs. The ideal candidate will have a proven track-record of... ...spending accounts, sponsored gym membership, an employee assistance program, life insurance, and much more. We also provide 401(...
Summer work
Local area
Work alone
Flexible hours
Nova Biomedical is hiring a Regulatory Affairs Specialist (Level II or Senior Level) in our Waltham, MA facility (Hybrid) to focus on assuring company compliance to US 510k, Health Canada Licensing, International Device Submissions, Licensing and Registration requirements...
The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials...
...Director, Regulatory Affairs
About the Company
Globally recognized biotechnology company
Industry
Biotechnology
Type
Privately Held
About the Role
The Director, Regulatory Affairs will be responsible for developing global regulatory strategies,...
...have you in front of a live recruiter.
The Opportunity
Description
We're looking for an Associate Director Regulatory Affairs CMC , working in Pharmaceuticals and Medical Products industry in Cambridge, Massachusetts, United States .
Leads development...