Manager, Regulatory Affairs CMC - Cambridge, United States - Takeda Development Center Americas, Inc

Manager, Regulatory Affairs CMC

2 weeks ago

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 Globa ...

Director, CMC Regulatory Affairs

3 days ago

Lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the primary interface with multiple internal and external stakeholders, including partners. Works as Global Regul ...

Associate Director, Regulatory Affairs CMC

1 week ago

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 under ...

Senior Manager, Regulatory Affairs CMC

1 week ago

The Senior Manager, Regulatory Affairs CMC supports RA CMC gene therapy development product(s) and provides support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. They will work closely with subject matter experts within CMC technical operations and QA workin ...

Associate Director Regulatory Affairs CMC

1 week ago

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 of robust global regulatory CMC strategy for assigned progra ...

Vice President, Regulatory Affairs, CMC

1 week ago

Why Join Us? · Please make sure you read the following details carefully before making any applications. · Be a hero for our rare disease patients · At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is alwa ...

Manager, Global Regulatory Affairs CMC

1 week ago

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I subm ...

Manager, Regulatory Affairs CMC

1 month ago

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...

Vice President, Regulatory Affairs, CMC

2 weeks ago

Why Join Us?Be a hero for our rare disease patients · At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease ...

Manager/Senior Manager, CMC Regulatory Affairs

1 week ago

Job Description · Great Science. Deep Compassion. Real Impact. · Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction. · We are inspired by the courage and dete ...

AD/Director, Regulatory Affairs CMC

22 hours ago

Position Summary : · The AD/Director, Regulatory Affairs CMC (Chemistry, Manufacturing and Controls) will be responsible to ensure that Zenas is executing global regulatory CMC strategies to support clinical development and commercialization readiness of biologic drug products a ...

AD/Director, Regulatory Affairs CMC

3 days ago

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global ...

Director, Regulatory Affairs Vaccines CMC

1 month ago

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...

Manager, Global Regulatory Affairs CMC

4 weeks ago

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...

CMC Regulatory Affairs Specialist

1 week ago

Job title: CMC Regulatory Technical Writer II · Location: Bridgewater, NJ, Hybrid · Duration: 1 year · SHIFT SCHEDULE 1st shift, 9-5 EST Mon-Fri · Pay Rate starts: $47/ HOUR · HM Notes: · Hybrid - onsite Tuesday & Thursday - This can change at any time. · 5 years exper ...

Regulatory Affairs CMC Officer

1 week ago

Be part of something altogether life-changing · Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative va ...

Project Manager, CMC Regulatory Affairs

3 weeks ago

At GSK, 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 cours Project Manager, Regulatory A ...

Project Manager, CMC Regulatory Affairs

3 weeks ago

Site Name: USA - Pennsylvania - Upper Providence, GSK House, UK - Hertfordshire - Ware, USA - Maryland - Rockville, USA - Massachusetts - Waltham, Zug House · Posted Date: May · At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion pe ...

Senior Manager, Regulatory Affairs CMC

2 weeks ago

Why Patients Need You · We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential, and the ever-changing regulatory environment requires forward thinking and attent ...

Regulatory Affairs CMC Officer

1 week ago

Be part of something altogether life-changing · Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative va ...