Regulatory Affairs Director
6 days ago
As a seasoned professional in regulatory affairs, you will be responsible for driving regulatory excellence across our organization. This role requires expertise in Companion Diagnostics, Clinical Trial Assays, and associated BioPharma programs. A background in regulatory frameworks within Oncology or Rare Diseases is highly valuable.
**Key Responsibilities:**
- Provide strategic regulatory guidance for CDx collaborations with BioPharma partners.
- Work closely with the BioPharma business team on strategic initiatives related to regulatory approvals and market access.
- Drive efforts to secure regulatory designations and contribute to CDx strategy development and submissions.
- Oversee and manage submissions for premarket approvals (PMAs), CTAs, IDEs, and other global regulatory filings.
Requirements:
10+ years of Regulatory Affairs experience in the pharmaceutical or diagnostics industry, including 5+ years in IVD. Proven track record of successful diagnostics regulatory submissions. Comprehensive knowledge of drug and diagnostic development processes, with the ability to interpret and apply regulatory guidance flexibly and strategically. Knowledge of Oncology regulatory frameworks is highly valuable.
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Regulatory Affairs Director
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Regulatory Affairs Director
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Boston, Massachusetts, United States Biolink360 Full timeBiolink360 seeks a seasoned Regulatory Affairs Director to lead our global pharmacovigilance efforts. The ideal candidate will have 12+ years of experience in regulatory affairs/pharmacovigilance and a strong background in developing regulatory strategies for new product development and registration.The successful candidate will oversee the management of our...
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Regulatory Affairs Director
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Boston, Massachusetts, United States Sophia Genetics SA Full timeJob DescriptionWe are seeking a highly experienced Regulatory Affairs Director to join our team. In this role, you will be responsible for providing strategic regulatory guidance and overseeing the development and implementation of regulatory strategies.Company Overview: Our company is a leader in the field of diagnostics and pharmaceuticals, with a strong...
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Regulatory Affairs Director
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Boston, Massachusetts, United States Proclinical Staffing Full timeJob DescriptionWe are seeking a Senior Director, CMC Regulatory Affairs to join our team at Proclinical Staffing. As a seasoned regulatory affairs expert, you will play a pivotal role in driving the global regulatory strategy for Chemistry, Manufacturing, and Controls (CMC). Your expertise will navigate complex regulatory landscapes, ensuring seamless...
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Regulatory Affairs Director
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Boston, Massachusetts, United States Jobot Full timeJobot is seeking a highly skilled Regulatory Affairs Director to lead the development and execution of global regulatory strategies for product development and approval. This pivotal role will ensure compliance with all applicable national and international regulations, standards, and guidance related to our products and operations.Key...
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Regulatory Affairs Director
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Boston, Massachusetts, United States Initial Therapeutics Full time**Job Description**We are seeking a highly skilled Regulatory Affairs Director to join our team at Initial Therapeutics. As a key member of our Global Regulatory Affairs CMC team, you will be responsible for overseeing the development and execution of regulatory CMC development and registration strategies.You will lead cross-functional teams in the...
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Regulatory Affairs Director
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Boston, Massachusetts, United States Monte Rosa Therapeutics, Inc Full timeCompany Overview">Monte Rosa Therapeutics, Inc is a leading biotechnology company dedicated to developing innovative therapies. We are seeking a highly skilled regulatory professional to join our team as an Associate Director of Regulatory Affairs.
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Regulatory Affairs Director
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Boston, Massachusetts, United States BioSpace, Inc. Full timeRegulatory Affairs Director Job Description:We are seeking a highly experienced Regulatory Affairs Director to join our team at BioSpace, Inc. As a key member of our regulatory affairs department, you will be responsible for overseeing all regulatory activities for multiple projects, including INDs, CTAs, briefing packages, responses, and other submissions....
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Regulatory Affairs Director
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Boston, Massachusetts, United States Phia LLC Full timeOur Story\SOPHiA GENETICS is a pioneer in the field of Data-Driven Medicine, driven by a passion to revolutionize healthcare through innovative technology and collaborative partnerships. As a leading provider of AI-powered diagnostic solutions, we are committed to empowering clinicians, researchers, and patients worldwide.\Your Mission\As our next Regulatory...
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Senior Director, Regulatory Affairs
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Boston, Massachusetts, United States Jobleads-US Full timeSenior Director, CMC Regulatory Affairs - Permanent - Boston, MA Ready to shape the future of biopharma innovation? Proclinical is seeking a dynamic, visionary leader who thrives at the intersection of science, strategy, and global regulatory frameworks. As our Senior Director of CMC Regulatory Affairs, you'll play a pivotal role in driving the regulatory...
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Regulatory Affairs Director
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Boston, Massachusetts, United States Proclinical Group Full timeWe are seeking a highly experienced Regulatory Affairs Director to lead our Chemistry, Manufacturing, and Controls (CMC) regulatory strategy. As part of our Proclinical Group team, you will play a pivotal role in driving the regulatory journey of cutting-edge product candidates from research breakthroughs to market approval.Your Impact:Strategize & Submit:...
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Regulatory Affairs Director
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Boston, Massachusetts, United States Proclinical Staffing Full timeJob DescriptionProclinical Staffing is seeking a dynamic leader to drive the regulatory journey of cutting-edge product candidates. As Senior Director, CMC Regulatory Affairs, you'll play a pivotal role in championing the global regulatory strategy for Chemistry, Manufacturing, and Controls (CMC). This involves navigating complex regulatory landscapes to...
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Regulatory Affairs Director
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Boston, Massachusetts, United States Takeda Full timeTakeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status,...
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Regulatory Affairs Director
4 days ago
Boston, Massachusetts, United States Proclinical Staffing Full timeAbout the RoleWe are seeking an accomplished Senior Director to lead our Chemistry, Manufacturing, and Controls (CMC) regulatory strategy. As a seasoned expert in biologics or bio-pharmaceuticals, you will champion our global CMC regulatory approach, navigating complex EU and US regulatory landscapes.You will drive cross-functional collaboration, integrating...
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Regulatory Affairs Director
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Boston, Massachusetts, United States EPM Scientific Full timeEPM Scientific seeks a seasoned Regulatory Affairs Director to lead our international regulatory efforts. As a key member of our team, you will develop and execute global regulatory strategies to support product registrations, market access, and compliance across key international markets.Key Responsibilities:Lead international regulatory submissions,...
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Senior Director of Regulatory Affairs
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Boston, Massachusetts, United States Olema Oncology Full timeAbout the RoleAs Senior Director, Global Regulatory Strategy - Regulatory Affairs, you will be responsible for leading cross-functional teams and providing strategic guidance on regulatory submissions, ensuring compliance with global health authority regulations. Your expertise will be instrumental in navigating complex regulatory landscapes and securing...
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Boston, Massachusetts, United States Jobot Full timeAssociate Director/Director Regulatory Affairs 4 days ago Be among the first 25 applicants Base pay range $185,000.00/yr - $250,000.00/yr Job Details REMOTE AD/Director Regulatory Affairs Opportunity-Medical Device We are currently seeking a dynamic, highly motivated, and experienced individual to join our team as an AD/Director of Regulatory Affairs in...