Regulatory Submissions Jobs in Waltham, MA

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Director, Project Toxicologist, Biopharma Safety I...

Astrazeneca

profile Waltham - USA

Job Title: Director Project Toxicologist BioPharma Safety in Clinical Pharmacology & Safety Sciences (CPSS)Location: Gaithersburg (MD) Waltham (MA) Boston (MA) Gothenburg (SE) Cambridge (UK).At AstraZeneca it is our bold ambition to achieve disease modification clinical remission and cure toimpactth...

7 hours ago
Full Time

Director, Epidemiology

Csl Plasma

profile Waltham - USA

CSL Behring is a global biotechnology leader guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35 nations and 30000 empl...

3 days ago
Full Time

Epidemiologist

Csl Plasma

profile Waltham - USA

CSL Behring is a global biotechnology leader guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35 nations and 30000 empl...

13 days ago
Full Time

Principal Regulatory Affairs Specialist

Bostonscientific

profile Waltham - USA

Additional Location(s):US-MN-Arden Hills; US-MA-WalthamDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees tackling so...

13 days ago
Full Time

Senior Manager, Regulatory Project Management And ...

Skyhawk Therapeutics

profile Waltham - USA

Senior Manager Regulatory Project Management and OperationsThe Senior Manager of Regulatory Project Management and Operations is responsible for leading the planning coordination and delivery of high-quality regulatory submissions to global health authorities. This role ensures submission readiness...

16 days ago
Contract

Executive Director, Head Of Clinical Science And M...

Csl Plasma

profile Waltham - USA

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing t...

17 days ago
Full Time

Director, Clinical Pharmacometrics

Xilio Therapeutics

profile Waltham - USA

Director Clinical PharmacometricsXilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O tr...

24 days ago
Full Time

Principal Biostatistician

Csl Plasma

profile Waltham - USA

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing t...

27 days ago
Full Time

Associate Director, Regulatory Affairs

Deciphera Pharmaceuticals

profile Waltham - USA

We are seeking a dynamic and strategic Associate Director Regulatory Affairs to join our Regulatory Affairs team. The Associate Director of Regulatory Affairs leads the development and execution of global regulatory strategies to support the approval and lifecycle management of pharmaceutical produc...

30+ days ago
Remote

Principal Scientistassociate Director, Precision M...

Abbvie

profile Waltham - USA

The Precision Medicine Immunology group is hiring an experienced translational and biomarker scientist with expertise in immunology who will be responsible for the development planning execution and interpretation of translational precision medicine activities in support of the immunology clinical d...

30+ days ago
Full Time

Medical Director, Clinical Development Neuroscienc...

Abbvie

profile Waltham - USA

Oversees the direction planning execution and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in cross-functional teams to generate deliver and interpret high-quality clinical data supporting overall product scientific and business...

30+ days ago
Full Time

Director Clinical Assay Strategy, Hematology And C...

Csl Plasma

profile Waltham - USA

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing t...

30+ days ago
Full Time

Director Clinical Assay Strategy Transplant & Immu...

Csl Plasma

profile Waltham - USA

CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined project-led structure and a focus on collaboration were building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile te...

30+ days ago
Full Time

Associate Director Clinical Assay Strategy Transpl...

Csl Plasma

profile Waltham - USA

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing t...

30+ days ago
Full Time

Principal Scientist, Clinical Assay Strategy X3

Csl Plasma

profile Waltham - USA

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing t...

30+ days ago
Full Time

Associate Director, Clinical Assay Strategy Vaccin...

Csl Plasma

profile Waltham - USA

Job DescriptionCSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed...

30+ days ago
Full Time

Associate Director Clinical Assay Strategy Transpl...

Csl Plasma

profile Waltham - USA

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing t...

30+ days ago
Full Time

Associate Director Clinical Assay Strategy, Hemato...

Csl Plasma

profile Waltham - USA

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing t...

30+ days ago
Full Time

Associate Director Clinical Assay Strategy, Hemato...

Csl Plasma

profile Waltham - USA

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing t...

30+ days ago
Full Time

Manager, Regional Regulatory Lead – Lcm

Csl Plasma

profile Waltham - USA

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing t...

30+ days ago
Full Time