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Regulatory Affairs Specialist
2 weeks ago
Synergy Solutions Hercules, United StatesEssential Onsite · - no hybrid. M-F 8:00 to 4:30 however we are flexible. · *Less than 1 year experience in IVD medical device industry is acceptable* · - Provide regulatory support for IVD products with multiple product groups within clinical diagnostics. · - Work with regulator ...
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Regulatory Affairs Director
1 week ago
BioLink 360 San Francisco, United StatesCompany Location: · Bay Area · Comp: · 150K-220K · Position Reports to: · VP of Regulatory and Quality · Director of Regulatory Affairs -San Francisco · We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Port ...
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Associate Director, Regulatory Affairs
1 week ago
Cytokinetics South San Francisco, United StatesReporting to the Senior Director, Regulatory Affairs, the Associate Director of Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies. · **Responsibilities** ...
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Specialist, Regulatory Affairs
1 week ago
Knewin San Francisco, United StatesAbout Pendulum · Pendulum is on a mission to help people improve physical and mental health by creating a new category of products that target the microbiome. We are researching, developing and commercializing a novel class of rationally-designed Live Synbiotics (probiotics + pr ...
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Regulatory Affairs Specialist
3 weeks ago
Katalyst Healthcares and Life Sciences San Francisco, United States Full timeResponsibilities: · Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products\' registration. · Participate on product development teams, providing regulatory s ...
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Regulatory Affairs Manager
1 day ago
Hinge Health San Francisco, United States Regular Full timeHinge Health is moving people beyond pain by transforming the way it is treated and prevented. Connecting people digitally and in-person with expert clinical care, we combine advanced technology, AI and a care team of experts to guide people through personalized care directly fro ...
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Head of Regulatory Affairs, Oncology
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Ascendis Pharma Palo Alto, United StatesHybridPalo Alto, California, United StatesOncology, Regulatory, OncologyFull time1404 · Description · We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, and Oncol ...
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Regulatory Affairs Specialist-4694
6 days ago
Infosoft Palo Alto, United StatesOne of our clients is looking for a talented and highly motivated **Sr. Regulatory Affairs Specialist**. Please **send your resume** if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position. · Here are the job position details for ...
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Senior Director Regulatory Affairs
6 days ago
Meet Recruitment San Francisco, United StatesThis range is provided by Meet. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. · Job Title: · Senior Director of Regulatory Affairs (Oncology Focus) · About Us: · We are parntered with a dynamic and innovative biotechnology ...
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Senior Director Regulatory Affairs
1 week ago
Meet San Francisco, United StatesThis range is provided by Meet. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. · Job Title: · Senior Director of Regulatory Affairs (Oncology Focus) · About Us: · We are parntered with a dynamic and innovative biotechnology ...
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Vice President Regulatory Affairs
1 week ago
Barrington James San Francisco, United StatesDirect message the job poster from Barrington James · Regulatory Affairs and Quality Assurance (Medical Devices) · Vice President Regulatory Affairs (Medical Device) - ONSITE in Bay Area · Our esteemed client, a inovative and growing medical device company specializing in the ma ...
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Senior Director Regulatory Affairs
1 week ago
SciPro San Francisco, United StatesSenior Director, Regulatory Affairs · San Francisco, CA (Hybrid) · Join this Bioscience company on the forefront of groundbreaking therapeutics I'm supporting a company seeking a dynamic individual for the role of Sr. Director, Regulatory Affairs. This pivotal position offers the ...
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Vice President of Regulatory Affairs
1 week ago
Dennis Partners San Francisco, United StatesThis clinical-stage biotech company is revolutionizing the treatment of cancer. They are seeking a Vice President of Regulatory Affairs to oversee all regulatory activities including serving as the primary contact with FDA and other regulatory agencies. You will develop and imple ...
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Regulatory Affairs Vice President
2 weeks ago
Dennis Partners San Francisco, CA, United StatesThis clinical-stage biotech company is revolutionizing the treatment of cancer. They are seeking a Vice President of Regulatory Affairs to oversee all regulatory activities including serving as the primary contact with FDA and other regulatory agencies. You will develop and imple ...
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Senior Director Regulatory Affairs
3 weeks ago
Scipro San Francisco, CA, United StatesSenior Director, Regulatory Affairs · San Francisco, CA (Hybrid) · Join this Bioscience company on the forefront of groundbreaking therapeutics I'm supporting a company seeking a dynamic individual for the role of Sr. Director, Regulatory Affairs. This pivotal position offers th ...
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Governmental and Regulatory Affairs Lead
1 week ago
Alga Biosciences San Francisco, United States[Full Time] Governmental and Regulatory Affairs Lead at Alga Biosciences (United States) | BEAMSTART Jobs · Governmental and Regulatory Affairs Lead · Alga Biosciences United States · Date Posted · 31 Oct, 2022 · Work Location · San Francisco, United States · Salary Offered · $ ...
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Vice President of Regulatory Affairs
2 weeks ago
Nusano West Valley City, United StatesOverview · Position Summary: · Nusano is seeking a dynamic and highly skilled Vice President of Regulatory Affairs & Quality Assurance to lead and oversee the regulatory and quality assurance functions at Nusano's state of-the-art facility in West Valley City, Utah. This role re ...
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Senior Director Regulatory Affairs
1 week ago
Life Science People San Francisco, United StatesThis range is provided by Life Science People. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. · Base pay range · $250,000.00/yr - $300,000.00/yr · Direct message the job poster from Life Science People · Provide regulatory g ...
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Vice President of Regulatory Affairs
1 week ago
Nusano West Valley City, United StatesOverview: · Position Summary: · Nusano is seeking a dynamic and highly skilled Vice President of Regulatory Affairs & Quality Assurance to lead and oversee the regulatory and quality assurance functions at Nusano's state of-the-art facility in West Valley City, Utah. This role ...
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Remote Regulatory Affairs Lead
3 weeks ago
Alga Biosciences San Francisco, CA, United StatesFull Time] Governmental and Regulatory Affairs Lead at Alga Biosciences (United States) | BEAMSTART Jobs Governmental and Regulatory Affairs Lead · Full Time · Remote Work · Stock Options · Alga Biosciences is a fast-moving startup on a mission to transform the agricultural i ...
AD/Director Regulatory Affairs - San Francisco, United States - Meet Recruitment
Description
Meets clinical-stage biopharmaceutical client based in the Bay Area is seeking a highly motivated individual to join their growing regulatory affairs group.
The Associate Director / Director, Regulatory Affairs will work closely with the Regulatory Affairs team and other departments to develop and implement regulatory strategies for the company's rare disease development programs.
The position will be onsite 3x per week.Responsibilities:
Providing strategic and operational regulatory support for collaboration with project team members, including regulatory colleagues.
Contributing to regulatory plans and strategies, proposing risk mitigation strategies, and influencing project teams across international locations.
Assist in the development and implementation of strategies for early regulatory approvals, preparing and managing technically complex submissions, offering regulatory advice to cross-functional teams, leading the drafting of responses to regulatory queries, and staying updated on regulatory requirements to communicate changes to other departments.
Qualifications:
Life Sciences Degree (MSc, MPH, PhD - preferred)
10 years of experience in pharmaceutical regulatory affairs, specifically in CMC regulatory affairs, with a strong track record in contributing to regulatory submissions.
Experience in small company settings and fast-paced environments is preferred.Proficiency in MS Word, Excel, PowerPoint, Visio, and Adobe Acrobat, along with experience in document formatting templates, is necessary.
Regulatory experience in the development of modified-release solid oral dosage forms is highly preferred, and experience with small molecule development is required.
Send a copy of your updated resume to to discuss the details further.#J-18808-Ljbffr