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Regulatory affairs Jobs in San Jose, CA

Last updated: 2 days ago
  • Promoted
Executive Director, Regulatory Affairs

Executive Director, Regulatory Affairs

Trebla TalentSunnyvale, CA, United States
Full-time
Senior Director / Executive Director of Regulatory Affairs.Bay Area (Remote - West Coast Preferred).This late-stage clinical biotech is pioneering a new class of complementary medicines for patients ...Show moreLast updated: 9 days ago
Regulatory Affairs Specialist

Regulatory Affairs Specialist

R&D PartnersCalifornia, CA
R&D Partners is seeking to hire a.Regulatory Affairs Specialist II.Your main responsibilities as a.Regulatory Affairs Specialist II : . Compile and maintain regulatory documentation databases or syste...Show moreLast updated: 30+ days ago
  • Promoted
(Senior) Director, International Regulatory Affairs

(Senior) Director, International Regulatory Affairs

Proclinical StaffingSan Jose, CA, United States
Permanent
Senior) Director, International Regulatory Affairs – Permanent – San Francisco Bay Area.Proclinical is seeking a (Senior) Director, International Regulatory Affairs for a growing biopharmaceutical ...Show moreLast updated: 25 days ago
Regulatory Affairs Process Specialist

Regulatory Affairs Process Specialist

Kelly Services, Inc.Sunnyvale, California, US
$47.00 hourly
Temporary
Kelly® Science & Clinical is seeking a Regulatory Affairs Process Specialist for a one-year contract opportunity with a leading molecular diagnostics company based in Sunnyvale, CA.If you are ...Show moreLast updated: 18 days ago
  • Promoted
Regulatory Affairs Specialist

Regulatory Affairs Specialist

LanceSoft, Inc.Santa Clara, CA, US
Full-time
Title : Regulatory Regulatory Affairs / Operations Specialist.Location : Santa Clara, CA- 95054.This role will provide compliance support to the Regulatory Affairs organization by –.Driving preparation...Show moreLast updated: 2 days ago
  • Promoted
Senior Associate, Regulatory Affairs

Senior Associate, Regulatory Affairs

Bayside SolutionsSanta Clara, CA, US
$83,200.00–$104,000.00 yearly
Full-time
Senior Associate, Regulatory Affairs.Redwood City, CA - Hybrid Role.As a Senior Associate of Regulatory Affairs, you will support Regulatory Affairs management in the day-to-day operational aspect ...Show moreLast updated: 7 days ago
Regulatory Affairs Intern

Regulatory Affairs Intern

Intuitive SurgicalSunnyvale, CA, United States
$41,600.00–$74,880.00 yearly
Full-time
At Intuitive, we are united behind our mission : we believe that minimally invasive care is life-enhancing care.Through ingenuity and intelligent technology, we expand the potential of physicians to...Show moreLast updated: 30+ days ago
  • Promoted
Regulatory Affairs Manager

Regulatory Affairs Manager

BioTalentSan Jose, CA, United States
Full-time
Regulatory Affairs Manager – Medical Devices.Lead regulatory strategy and submissions for medical device products, including FDA 510(k), Q-subs, and international market approvals.Oversee regulator...Show moreLast updated: 3 days ago
Regulatory Affairs Process Specialist

Regulatory Affairs Process Specialist

Kelly ServicesSunnyvale, CA, US
$47.00 hourly
Full-time
Kelly® Science & Clinical is seeking a Regulatory Affairs Process Specialist for a one-year contract opportunity with a leading molecular diagnostics company based in Sunnyvale, CA.If you are d...Show moreLast updated: 18 days ago
  • Promoted
Vice President Regulatory Affairs

Vice President Regulatory Affairs

Meetsunnyvale, CA, United States
We are excited to partner with a rapidly growing biotech company that is pioneering the development of novel therapies.With a strong financial foundation and a pipeline of innovative clinical-stage...Show moreLast updated: 5 days ago
Regulatory Affairs Analyst

Regulatory Affairs Analyst

San Jose Water CompanySan Jose, CA, US
Founded in 1866, San Jose Water Company is an investor owned water company headquartered in Silicon Valley.With a service area of 140 square miles, it is one of the largest and most technically sop...Show moreLast updated: 30+ days ago
  • Promoted
Director / Sr. Director Regulatory Affairs

Director / Sr. Director Regulatory Affairs

Pulmonx CorporationSan Jose, CA, US
$200,000.00–$240,000.00 yearly
Director of Regulatory Affairs.Director level depending upon experience.Workplace type : Hybrid (Remote will be considered for candidates in the western US). Responsibilities and Capabilities : .Create...Show moreLast updated: 7 days ago
REGULATORY AFFAIRS SPECIALIST 3.

REGULATORY AFFAIRS SPECIALIST 3.

Intellipro GroupCalifornia
$50.00 hourly
Position : Sr Regulatory Affairs SpecialistLocation : Sunnyvale, CaliforniaPosition Type : Contract Date : 02 / 21 / 2023Salary : Starting at $50. The Sr Regulatory Affairs Specialist is responsible for ensu...Show moreLast updated: 30+ days ago
  • Promoted
Regulatory Affairs Specialist 3

Regulatory Affairs Specialist 3

IntuitiveSunnyvale, California, USA
Full-time
New Product / Indication Submissions.Provide regulatory insight to development new product introduction and manufacturing teams for assessing the impact of design inputs and outputs on regulatory fil...Show moreLast updated: 4 days ago
Regulatory Affairs Manager

Regulatory Affairs Manager

Katalyst HealthCares & Life SciencesSan Jose, CA
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: 30+ days ago
Sr Regulatory Affairs Specialist

Sr Regulatory Affairs Specialist

DexcomRemote California
$87.00 hourly
Remote
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM).Dexcom began as a small company with a big dream : To forever change how diabetes is managed.To...Show moreLast updated: 30+ days ago
  • Promoted
Regulatory Affairs Specialist

Regulatory Affairs Specialist

ACE PartnersSan Jose, CA, United States
$110,000.00–$120,000.00 yearly
Full-time
Regulatory Affairs Specialist – Medical Devices.Working knowledge of FDA 510(k) submissions is a must.This role offers an exciting opportunity to contribute to regulatory compliance and support a c...Show moreLast updated: 19 days ago
Director, Regulatory Affairs

Director, Regulatory Affairs

Stryker Employment Company, LLCSan Jose, California
Full-time
United States, Canada and Europe.Through close partnership with business unit leadership, Marketing, R&D, Clinical and Quality teams, the Director will develop and advise on product positioning, pr...Show moreLast updated: 30+ days ago
Regulatory Affairs Manager

Regulatory Affairs Manager

IntelliPro Group Inc.Sunnyvale, CA, US
$100,000.00–$150,000.00 yearly
Quick Apply
Regulatory Affairs Manager Location - Sunnyvale, CA Full time Salary - $100k - $150k + Benefits Bachelor’s degree in Science, Engineering, Math, a medical field, or an equivalent ...Show moreLast updated: 30+ days ago
Executive Director, Regulatory Affairs

Executive Director, Regulatory Affairs

Trebla TalentSunnyvale, CA, United States
9 days ago
Job type
  • Full-time
Job description

Role : Senior Director / Executive Director of Regulatory Affairs

Location : Bay Area (Remote - West Coast Preferred)

About the Company :

This late-stage clinical biotech is pioneering a new class of complementary medicines for patients battling neurodegenerative and autoimmune disorders. The company is expanding its regulatory team following groundbreaking positive data from its successful Phase 3 trial.

The Role :

With exciting plans to file its first BLA in 2025, the team is naturally expanding! This ED / SD will report to the Head of Regulatory Affairs and provide strategic regulatory leadership for its upcoming BLA submission and additional NDA / MAA submissions.

  • Lead NDA and MAA Regulatory Strategy while supporting the ongoing BLA
  • Directly interface with FDA and EMA.
  • Make hiring decisions as the Regulatory team expands

What We're Looking For :

  • 15+ years of industry experience across Regulatory Affairs and Strategy
  • Hands-on experience supporting and / or leading BLAs or NDAs
  • Prior experience leading, managing, and developing late-stage clinical programs.
  • Rare Disease, Neurology or Autoimmune experience preferred.
  • If you are interested in the Executive Director of Regulatory Affairs, please reach out to [email protected].