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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...
Suggested
...revolutionary way?
What if you could be the first hire in Regulatory Affairs with the opportunity to build a strategy and your team as... ...years of experience in regulatory affairs within the biotech/pharmaceutical industry. Biotech experience preferred.
* Demonstrated...
Pharmaceutical
Shift work
3 days per week
...applying advanced knowledge of global regulations governing pharmaceutical drug development and commercialization to all aspects of assigned... ...of products while maintaining compliance with all regulatory requirements and commitments. Evaluates proposed regulations...
Pharmaceutical
Remote job
Contract work
Local area
Night shift
...#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...
Suggested
Work from home
Night shift
2 days per week
1 day per week
...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 proactively in a cross-...
Pharmaceutical
Flexible hours
...disease.
Description:
Reporting to the Sr. Director of Regulatory Affairs and Policy, this role will support and lead activities... ...in life sciences, MS preferred
At least 6-8 years of pharmaceutical product development
Responsibilities:
Deliver on the...
Pharmaceutical
Local area
Remote job
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...
Suggested
...Position Summary:
Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling, the Director, Regulatory... ...environment as it relates to advertising and promotion of pharmaceutical products and devices. Advise appropriate departments within...
Pharmaceutical
...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...
Suggested
...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...
Suggested
Local area
Work from home
Worldwide
Night shift
...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 and execution...
Pharmaceutical
...Director, Regulatory Affairs
About the Company
Globally recognized biotechnology company
Industry
Biotechnology
Type
Privately... ...At least 10 years' of experience in the biotechnical or pharmaceutical industry required
Experience working as a lead in...
Pharmaceutical
...The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products... ...of CMC drug development process/requirements within pharmaceutical and/or biopharmaceutical industries and GMP requirements as...
Pharmaceutical
...therapies to patients worldwide.
Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and... ...5 years relevant vaccines or biologics experience (e.g. Pharmaceutical Development, Process Development, Analytical Development, Production...
Pharmaceutical
Minimum wage
Holiday work
Full time
Temporary work
Local area
Remote job
Worldwide
...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 modifications,...
Suggested
Worldwide
The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies... ...Affairs, including all associated requirements
Pharmaceutical industry experience in successfully transitioning from...
Pharmaceutical
...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...
...remote.
PURPOSE AND SCOPE:
Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of... ...coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison...
Pharmaceutical
Remote job
Work experience placement
Local area
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...
...Job Description Vaco has partnered with our client to hire a Regulatory Contractor for a 12- 18 month assignment.
Where: 100% Remote... ...A minimum of 6 months to 5 years of experience in Regulatory Affairs of a Consumer Products Company with working knowledge of U.S....
Contract work
For contractors
Local area
Immediate start
Remote job
