Sr. Director, Clinical Regulatory Affairs
3 weeks ago
- Minimum 10 years of experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role required
- Experience supporting clinical development teams in the autoimmune disease space is a must
- Provides regulatory guidance and input to project teams
- Designs and implements regulatory strategies to obtain and maintain clinical trial applications
- Oversees the creation and submission of all regulatory filings
- Extensive knowledge of non-clinical and clinical development, regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA and other international regulatory agencies
- Demonstrated track records of successful regulatory meetings, IND or BLA submissions and approvals
- Experience in Oncology and Immuno-oncology is preferred but not required
- Arranges for and leads meetings with global health authorities as needed
- Provides training and mentorship to regulatory staff and other junior staff at the company
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Director, CMC Regulatory Affairs
2 weeks ago
Watertown, United States Alkermes Full timeJob DescriptionOverview: 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 determination of individuals living with complicated and often difficult-to-treat...
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Regulatory Affairs Specialist II/Sr.
1 month ago
Watertown, United States CareerBuilder Full timeCareer Opportunities with Nova Biomedical Corporation Nova Biomedical is an Equal Opportunity Employer in compliance with Affirmative Action in hiring and promoting women, minorities, veterans and individuals with disabilities. Nova Biomedical is hiring a Regulatory Affairs Specialist (Level II or Senior Level) in our Waltham, MA facility (Hybrid) to focus...
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Associate Director Regulatory Affairs
4 days ago
Watertown, United States Sherlock Biosciences Full timeJob DescriptionJob DescriptionSalary: OverviewSherlock Biosciences is dedicated to providing global access to the simplest and most accurate diagnostic tests that empower individuals to control their own healthcare. We are creating a new generation of CRISPR and Synthetic Biology-based molecular diagnostic technology platforms that can rapidly deliver...
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VP, Regulatory Affairs
4 days ago
Watertown, United States Vigil Neuroscience Full timeVigil Neuroscience is the world’s first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain’s immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to...
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Watertown, United States GlaxoSmithKline, plc Full timeEnsure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. This goal must be achi Regulatory Affairs, Medicine, Director, Precision, Health, Regulatory
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VP, Regulatory Affairs
1 month ago
Watertown, United States Vigil Neuroscience, Inc. Full timeVigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to...
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Manager, Regulatory Affairs
4 days ago
Watertown, United States Deciphera Pharmaceuticals Full timeCompany Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. Enabled by...
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VP, Regulatory Affairs
4 weeks ago
Watertown, United States Vigil Neuroscience, Inc. Full timeJob DescriptionJob DescriptionVigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. We are utilizing the tools of modern neuroscience drug development across...
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VP, Regulatory Affairs
4 weeks ago
Watertown, United States Vigil Neuroscience Full timeVigil Neuroscience is the world’s first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain’s immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to...
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VP, Regulatory Affairs
4 weeks ago
Watertown, United States Vigil Neuroscience Full timeVigil Neuroscience is the world’s first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain’s immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to...
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VP, Regulatory Affairs
4 weeks ago
Watertown, United States Vigil Neuroscience Full timeVigil Neuroscience is the world’s first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain’s immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to...
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Manager/Senior Manager, CMC Regulatory Affairs
3 weeks ago
Watertown, United States Alkermes Full timeJob 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 determination of individuals living with complicated and often difficult-to-treat diseases....
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Watertown, United States Fresenius Medical Care Full timeThis position can be fully remoteGlobal Regulatory experience needed.Demonstrated project management experience needed.PURPOSE AND SCOPE:Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Develops, coordinates, reviews and prepares documentation packages for...
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Director, Clinical Operations
4 days ago
Watertown, United States Kymera Therapeutics, Inc. Full timeWho we are: Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients' lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having...
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Sr. Manager GCP quality Assurance
1 week ago
Watertown, United States Planet Pharma Full timeJob Description: Interested in this role You can find all the relevant information in the description below. Playing a critical role , the Sr. Manager, GCP Quality Assurance will be relied upon as Subject Matter Expert in providing GCP Quality Assurance and Compliance support with respect to planning, execution and close-out of clinical programs. The Sr....
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Executive Director, Clinical Development
3 weeks ago
Watertown, United States Alkermes Full timeJob Description Position Overview This is a high impact position with great visibility across all levels of the Alkermes organization. This position will have critical hands-on leadership responsibilities in the clinical department involved in the development of therapies for neurology indications, including sleep disorders. Key domains include development...
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Senior Medical Director
4 days ago
Watertown, United States C4 Therapeutics, Inc. Full timeAbout C4 Therapeutics: C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients' lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO...
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Watertown, United States Fresenius Medical Care Full timeThe ideal candidate should have US Advertising and Promotion experience.This position can be fully remote.PURPOSE AND SCOPE:Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical...
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Senior Medical Director
3 days ago
Watertown, United States C4 Therapeutics Inc Full timeJob DescriptionJob DescriptionAbout C4 Therapeutics:C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies...
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Senior Medical Director
3 days ago
Watertown, United States C4 Therapeutics Inc Full timeJob DescriptionJob DescriptionAbout C4 Therapeutics:C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies...