Regulatory affairs manager Jobs in USA
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Regulatory affairs manager • usa
Last updated: 15 hours ago
Salary depending on experience.Founded in 1998, Huisong Pharmaceuticals specializes in the R&D and manufacturing of premium-quality natural ingredients for world-leading companies in the pharma...Show moreLast updated: 20 days ago
At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world.Rhythm is shaping a future where everyone, everywhere can access the...Show moreLast updated: 7 days ago
Regulatory Affairs Manager Company: VistaApex Solutions Location: Racine, WI | Hybrid (3 days per week in-office) Reports to: Director of Engineering, Regulatory and Quality About VistaApex Solutio...Show moreLast updated: 30+ days ago
KPI Bonuses + Competitive Benefits.This position is responsible for supporting strategies and operations of the organization's regulatory affairs function, which ensures compliance with governmenta...Show moreLast updated: 30+ days ago
Executive/Director/Management, Allied Health, Grant or Research Administration, Health Care Administration/Support, Legal/Audit Services/Compliance.Classification Minimum Requirements:.Master's deg...Show moreLast updated: 13 days ago
At Roche you can show up as yourself, embraced for the unique qualities you bring.Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted ...Show moreLast updated: 7 days ago
Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements.In addition, this position serves as a...Show moreLast updated: 14 days ago
Grid United is a mission-driven company aiming to solve the largest barrier to a more reliable, resilient and affordable grid by developing new long haul electric transmission lines in the United S...Show moreLast updated: 30+ days ago
Maze Therapeutics is seeking a.In this role, you will collaborate closely with cross-functional teams to coordinate regulatory submissions, support interactions with Health Authorities, and help dr...Show moreLast updated: 1 day ago
The Manager, Regulatory Affairs drives key regulatory activities, working seamlessly across functions to translate scientific, clinical, and technical insights into high-quality regulatory submissi...Show moreLast updated: 15 hours ago
Regulatory submissions including Original ANDAs, Amendments, Annual Reports, Supplements and PADERs to company applications.Preparation/Review of Original submission/Amendments/ Supplements as assi...Show moreLast updated: 7 days ago
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecula...Show moreLast updated: 8 days ago
Cerapedics is a global, commercial-stage ortho-biologics company that aspires to transform the standard of care for bone repair, healing bones faster and at higher rates, without compromising safet...Show moreLast updated: 7 days ago
Regulatory Affairs Manager Job Description.Manage Company’s Regulatory Affairs for assigned products for US and Canada, including implementation of the overall regulatory strategy, preparation of r...Show moreLast updated: 30+ days ago
McKesson’s Controlled Substances Monitoring Program (CSMP) is seeking a Regulatory Affairs Manager (RAM) to join our team in support of our SoCal, Sacramento, and Honolulu Distribution Centers.This...Show moreLast updated: 5 days ago
It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at.We’re a team of engineers, clin...Show moreLast updated: 10 days ago
The preferred location for this position is Austin, TX.Qualified candidates within Entergy’s service territory may be considered in addition to Austin, TX.Relocation assistance may be considered.Ma...Show moreLast updated: 30+ days ago
The Regulatory Affairs Manager is responsible for monitoring, interpreting, and influencing regulatory and standards requirements that impact HVAC products and systems within the West Coast region,...Show moreLast updated: 7 days ago
Job Title: Manager Regulatory Affairs Location: Morristown, NJ Cambridge, MA About the Job Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research.In R&D, you...Show moreLast updated: 1 day ago
Regulatory Affairs Manager
Huisong PharmaceuticalsSanta Ana, California, United StatesPart-time
Quick Apply
- Promoted
Manager, Regulatory Affairs
iRhythm TechnologiesAnaheim, CA, United StatesFull-time
Regulatory Affairs Manager
VistaApex SolutionsRacine, WI, USFull-time
Quick Apply
Regulatory Affairs Manager
Pedernales Electric CooperativeAustin, TX, USFull-time
- Promoted
Regulatory Affairs Manager
InsideHigherEdGainesville, Florida, United StatesFull-time
- Promoted
Regulatory Affairs Project Manager / Regulatory Affairs Manager
RocheSanta Clara, CA, United StatesFull-time
Regulatory Affairs Manager
Katalyst HealthCares & Life SciencesDanbury, CTFull-time
Regulatory Affairs Manager
Grid UnitedHouston, Texas, United StatesFull-time
- Promoted
Manager, Regulatory Affairs
Maze TherapeuticsSouth San Francisco, CA, United StatesFull-time
- Promoted
- New!
Manager, Regulatory Affairs
Precision BioSciences IncDurham, NC, United StatesFull-time
- Promoted
Regulatory Affairs Manager
Katalyst Healthcares and Life SciencesSunnyvale, CA, United StatesFull-time
- Promoted
Regulatory Affairs Manager
QuidelOrthoLos Angeles, CA, United StatesFull-time
- Promoted
Regulatory Affairs Manager
CerapedicsLouisville, CO, United StatesFull-time
- Promoted
Regulatory Affairs Manager
Clinical Dynamix, Inc.Bridgewater, NJ, USFull-time
Quick Apply
Regulatory Affairs Manager
McKessonRemote, NV, USARemote
Full-time
Regulatory Affairs Manager
Intuitive SurgicalSunnyvale, United StatesFull-time
Manager, Regulatory Affairs
EntergyAustin, Texa, UnFull-time
- Promoted
Regulatory Affairs Manager
DaikinSanta Clara, CA, United StatesFull-time
Manager Regulatory Affairs
Sanofi EUMorristown, New Jersey, USFull-time
The average salary range is between $ 112,721 and $ 164,872 year , with the average salary hovering around $ 134,513 year .
Regulatory Affairs Manager
Huisong PharmaceuticalsSanta Ana, California, United States20 days ago
Job type
- Part-time
- Quick Apply
Job description
Regulatory Affairs Manager
Santa Ana, CA
Part-time Employee
Salary depending on experience.
About Huisong:
Founded in 1998, Huisong Pharmaceuticals specializes in the R&D and manufacturing of premium-quality natural ingredients for world-leading companies in the pharmaceutical, nutraceutical, food & beverage, and personal care industries. Today, Huisong Pharmaceuticals is a global operation with an extensive and dynamic product portfolio of natural products and ingredients, remaining firm in its values of "Nature, Health, Science", and continues to advance the world of medicine and nutrition for the well-being of humanity.
Official Company Website: https://www.huisongpharm.com/
Job Description:
- Develop and execute global regulatory strategies for new and existing products (e.g., dietary supplements, herbal extracts, TCM).
- Lead FDA submissions (e.g., NDIN, GRAS, OTC monographs) and international registrations (e.g., EU Novel Food, Health Canada NHP).
- Advise senior management on emerging regulations (e.g., FDA’s NDIN updates, Prop 65, FSMA).
- Ensure compliance with cGMP, 21 CFR 111/117, ISO 9001, and organic certifications (USDA, EU).
- Manage regulatory audits (FDA, NSF, customer audits) and lead corrective actions.
- Oversee labeling and claims review per FDA/FTC guidelines (e.g., structure/function claims, TCM disclosures).
- Collaborate with R&D, Sales, and Supply Chain to align regulatory requirements with business goals.
- Liaise with global suppliers to ensure raw material compliance (e.g., adulteration testing, heavy metals, pesticide limits).
- Navigate TCM-specific regulations (e.g., USP Herbal Compendium, WHO guidelines, China NMPA standards).
- Address challenges in botanical adulteration, safety data, and traditional use claims.
Education and Experience Requirements:
- Bachelor's degree or equivalent in pharmacy, chemistry, food science, or herbal medicine; RAC certification a plus.
- 5+ years in regulatory affairs (nutraceuticals, botanicals, or TCM) with 2+ years in a leadership role.
- Deep knowledge of: FDA 21 CFR 111/117, DSHEA, NDIN, GRAS, cGMP, ISO9001, FSVP, and global supplement regulations.
- Proven track record in FDA/EU submissions and managing audits.
Benefits:
- Medical Insurance.
- Vision Insurance.
- Dental Insurance.