- 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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Lead Regulatory Affairs Director
5 days ago
Aspartes Pharmaceuticals Cambridge, United States**Position Overview**: · We are seeking an exceptionally talented lead Regulatory Affairs director with a high level of experience in the rare/ultra-rare disease space. The role is centered around providing key insight and regulatory input for the development of a small molecule ...
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Principal Regulatory Affairs Specialist
3 days ago
Philips Cambridge, United States**Job Title**: Principal Regulatory Affairs Specialist · **Principal Regulatory Affairs Specialist · - Software & Artificial Intelligence (U.S. Hub Based)** · The Principal Regulatory Affairs Specialist · - SW & AI will shape, lead and execute innovative regulatory strategies to ...
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Director of Regulatory Affairs
6 days ago
Dyne Therapeutics Waltham, United StatesCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide the ...
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Manager, Regulatory Affairs
3 days ago
Deciphera Pharmaceuticals Waltham, United StatesJob Description · Job DescriptionCompany 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 inhib ...
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Director of Regulatory Affairs
1 week ago
Dyne Therapeutics Waltham, United StatesCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide the ...
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VP, Regulatory Affairs
6 days ago
Vigil Neuroscience Watertown, United StatesVigil 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 mo ...
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Director, Regulatory Affairs
3 weeks ago
Dyne Therapeutics Waltham, United States Full timeCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide the ...
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VP, Regulatory Affairs
1 week ago
Vigil Neuroscience Watertown, United StatesVigil Neuroscience is the worlds 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 brains immune system. We are utilizing the tools of mode ...
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Regulatory Affairs Director
2 weeks ago
AstraZeneca Watertown, United StatesAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious disease. AstraZeneca's pipeline of industry-leading innovative medicines ...
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VP, Regulatory Affairs
2 days ago
Vigil Neuroscience, Inc. Watertown, United StatesJob Description · Job 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. ...
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Regulatory Affairs Cmc Officer
2 days ago
Cytiva Marlborough, United States**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 ...
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Senior Regulatory Affairs Director
2 weeks ago
AstraZeneca Waltham, United StatesWould you like to apply your global Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines?At AstraZeneca, we do this with the upmost integrity even in the most difficult situations be ...
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Senior Regulatory Affairs Director
1 week ago
AstraZeneca Waltham, MA, United StatesWould you like to apply your global Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines?At AstraZeneca, we do this with the upmost integrity even in the most difficult situations be ...
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Director, CMC Regulatory Affairs
5 days ago
Alkermes Waltham, United StatesJob Description · Overview: · 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 cou ...
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Director, Regulatory Affairs Vaccines Cmc
3 days ago
ARIAD Boston, United States**Pay Range**: · $169, $266,200.00 · **Job ID** R0120763**Date posted** 04/16/2024**Location** Boston, Massachusetts**Pay Range** $169, $266,200.00**About the role**: · At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transfor ...
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Senior Director Regulatory Affairs
18 hours ago
Fresenius Kidney Care Waltham, United StatesSenior Director Regulatory Affairs page is loaded · Senior Director Regulatory Affairs · Apply · locations · Waltham, MA, USA · time type · Full time · posted on · Posted 3 Days Ago · job requisition id · R · This is a remote position with 25% travel · PURPOSE AND SCOP ...
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Director, CMC Regulatory Affairs
1 week ago
Alkermes Waltham, United States Full timeOverview: · 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 determinatio ...
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Regulatory Affairs
2 weeks ago
Verily Boston, MA, United StatesVerily is a subsidiary of Alphabet that is using a data-driven approach to change the way people manage their health and the way healthcare is delivered. Launched from Google X in 2015, our purpose is to bring the promise of precision health to everyone, every day. We are focused ...
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Director, CMC Regulatory Affairs
4 weeks ago
Tscanrx Waltham, United StatesWe are looking for an experienced CMC professional to join our team as a Director of CMC Regulatory Affairs supporting our growing pipeline of TCR T-cell therapies.The Director of CMC Regulatory Affairs will be responsible for supporting and leading the development and implementa ...
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Senior Regulatory Affairs Director
2 weeks ago
AstraZeneca, plc Watertown, United StatesThe Senior Regulatory Affairs Director (SRAD) serves as the Franchise Global Regulatory Lead (GRL) developing and implementing the global strategy on complex oncology programs with multiple indications. In addition, the SRAD has the ability to functi Regulatory Affairs, Director, ...