Director, Regulatory Affairs CMC

**Pay Range**: $169,400.00 - $266,200.00 **Job ID** R0120763**Date posted** 04/16/2024**Location** Boston, Massachusetts**Pay Range** $169,400.00 - $266,200.00**About the role**: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four...

**About the role**: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join...

Our client is developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders. They are seeking a Regulatory CMC Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product. Reporting into the Senior Director Regulatory CMC,...

Consultant Regulatory CMC- Permanent - Boston, MAProclinical is seeking a Senior Regulatory Affairs Associate or a Regulatory Affairs Consultant with a strong background in CMC post-approval. This permanent position is located in Boston, MA.Primary Responsibilities:The successful candidate will provide lifecycle management support to a broad, global...

Company Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...

Company OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...

Job#: 2025096 Job Description: Associate Director/Director, Regulatory Affairs 2025096 Location:  Boston, MA(Remote) Therapeutic Areas : Neuro Job Overview: The Associate Director/Director will develop and implement global regulatory strategies, serving as the regulatory lead for clinical studies and obtaining necessary approvals for initiation,...

Lead the regulatory efforts for IND-enabling activities, including the preparation of the Investigational New Drug (IND) application for our groundbreaking oncology and CNS therapies targeted for submission this year and early next. Be the go for all things regulatory and acting as a key voice to the future of all trials, SOPs and strategy for these early...

About the JobThe Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMI's unparalleled global portfolio of assay products, including companion diagnostics. This role is responsible for international regulatory strategy, including...

Consultant Regulatory CMC - Permanent - Boston, MAProclinical is seeking a Senior Regulatory Affairs Associate or a Regulatory Affairs Consultant with a strong background in CMC post-approval. This permanent position is located in Boston, MA.Primary Responsibilities:The successful candidate will provide lifecycle management support to a broad, global...

Senior Director, Regulatory Affairs - Permanent - RemoteProclinical Staffing is seeking a Senior Director, Regulatory Affairs to join a leading health information technology and clinical research organization. This is a permanent role with the opportunity to work remotely.Primary ResponsibilitiesIn this role, you will provide leadership and advice on the...

Job DescriptionThe Director, CMC will develop and manage manufacturing and packaging operations for clinical and commercial drug substance and drug products at contract manufacturing (CMO) facilities.Job Responsibilities· Manage and interface with CMOs (including person-in-plant (PIP) activities as needed) to ensure drug substance, finished dosage form and...

Job DescriptionThe Director, CMC will develop and manage manufacturing and packaging operations for clinical and commercial drug substance and drug products at contract manufacturing (CMO) facilities.Job Responsibilities· Manage and interface with CMOs (including person-in-plant (PIP) activities as needed) to ensure drug substance, finished dosage form and...

DescriptionAbout Us:As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community by leading innovation across our system. Founded by Brigham and Women’s Hospital and Massachusetts General Hospital, Mass General Brigham supports a complete continuum of care including...

Job DescriptionJob DescriptionCompass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass' scientific focus is on the relationship between angiogenesis, the immune system and tumor growth. Our pipeline of novel product candidates is...

The Senior Director, Federal Government Affairs will manage BCBSMA activities to achieve effective and time-sensitive advancement of BCBSMA legislative and regulatory agenda in a coordinated and integrated fashion. Key Accountabilities: Manage BCBSMA Director, Senior, Regulatory Affairs, Vice President, Government, Insurance, Policy

For Current Gilead Employees and Contractors:Please log onto your Internal Career Site $) to apply for this job.At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access...

HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases...

Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple areas of the...

Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple areas of the...