Talent.com

Regulatory affairs Jobs in San Jose, CA

Last updated: 8 hours ago
  • Promoted
DIRECTOR, REGULATORY AFFAIRS

DIRECTOR, REGULATORY AFFAIRS

Revolution MedicinesCA, United States
$204,000.00–$255,000.00 yearly
Full-time
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline com...Show moreLast updated: 1 day ago
  • Promoted
Regulatory Affairs Project Manager

Regulatory Affairs Project Manager

GForce Life SciencesSanta Clara, CA, United States
Temporary
Regulatory Affairs Project Manager (Individual Contributor Role).This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems.Applies adv...Show moreLast updated: 11 days ago
  • Promoted
International Regulatory Affairs Director

International Regulatory Affairs Director

Keystone & Golden, Inc.San Jose, CA, US
Full-time
An industry-leading nutraceutical company is seeking an.International Regulatory Director.This role is responsible for ensuring compliance with international regulations, managing product registrat...Show moreLast updated: 1 day ago
  • Promoted
Director / Senior Director, Regulatory Affairs

Director / Senior Director, Regulatory Affairs

Hobson PriorSan Mateo County, CA, United States
Full-time
Hobson Prior is seeking a Director / Senior Director, Regulatory Affairs Labelling, Advertising, and Promotion to join the team. This role will focus on overseeing the labelling process for various ...Show moreLast updated: 3 days ago
  • Promoted
EXECUTIVE DIRECTOR, REGULATORY AFFAIRS CMC

EXECUTIVE DIRECTOR, REGULATORY AFFAIRS CMC

ExelixisCA, United States
Full-time
This role provides CMC Regulatory expertise and leadership for commercial and development projects.This role leads all regulatory activities related to chemistry, manufacturing, and controls (CMC) ...Show moreLast updated: 4 days ago
  • Promoted
Vice President Regulatory Affairs

Vice President Regulatory Affairs

MeetSanta Clara, CA, United States
Full-time
Vice President, Regulatory Affairs.Hybrid Workstyle (2-3x per week onsite in South San Francisco, CA).Meet has partnered with an exciting biotech that is looking for a Vice President of Regulatory ...Show moreLast updated: 1 day ago
  • Promoted
(Senior) Director, International Regulatory Affairs

(Senior) Director, International Regulatory Affairs

Proclinical StaffingSanta Clara, 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: 3 days ago
  • Promoted
Manager, Regulatory Affairs

Manager, Regulatory Affairs

Outset MedicalSan Jose, CA, United States
$130,000.00 yearly
Full-time
Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with prog...Show moreLast updated: 1 day ago
  • Promoted
  • New!
SENIOR DIRECTOR, CLINICAL REGULATORY AFFAIRS

SENIOR DIRECTOR, CLINICAL REGULATORY AFFAIRS

ArcellxCA, United States
Full-time
Arcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases.We believe that cel...Show moreLast updated: 8 hours ago
Regulatory Affairs Manger

Regulatory Affairs Manger

Katalyst HealthCares & Life SciencesSanta Clara, CA
Provide input to global regulatory submission strategy, preparing regulatory submission documents, and reviewing regulatory submissions for completeness and quality in global accordance with regula...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
Full-time
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: 3 days ago
  • Promoted
Sr. Regulatory Affairs Specialist I

Sr. Regulatory Affairs Specialist I

Align TechnologySan Jose, CA, US
Full-time
Regulatory Affairs Specialist I will be responsible for regulatory activities for Software as Medical Device (SaMD) registrations and maintenance of sustaining product. In addition, this role will b...Show moreLast updated: 11 days ago
  • Promoted
DIRECTOR / SENIOR DIRECTOR, REGULATORY AFFAIRS

DIRECTOR / SENIOR DIRECTOR, REGULATORY AFFAIRS

SolenoCA, United States
Full-time
Redwood City, California, is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, including Prader-Willi syndrome (PWS).At Soleno, we are dri...Show moreLast updated: 1 day ago
  • Promoted
Sr Manager Regulatory Affairs

Sr Manager Regulatory Affairs

Imperative CareCampbell, CA, US
$180,000.00 yearly
Full-time
Do you want to make a real impact on patients?.As part of our team at Imperative Care, you can help elevate care for patients suffering from stroke and other devastating vascular diseases.Every day...Show moreLast updated: 1 day 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
  • Promoted
DIRECTOR / SR. DIRECTOR, REGULATORY AFFAIRS

DIRECTOR / SR. DIRECTOR, REGULATORY AFFAIRS

BridgeBio PharmaCA, United States
Full-time
About Calcilytix & BridgeBio Pharma.BridgeBio Pharma, is developing encaleret (CLTX-305), a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Domin...Show moreLast updated: 1 day ago
  • Promoted
  • New!
Regulatory Affairs Associate

Regulatory Affairs Associate

VirtualVocationsSunnyvale, California, United States
Full-time
A company is looking for a Regulatory Affairs Associate.Key ResponsibilitiesProvide daily regulatory support to achieve organizational goals and strategiesSupport third-party certification processe...Show moreLast updated: 11 hours ago
DIRECTOR, REGULATORY AFFAIRS

DIRECTOR, REGULATORY AFFAIRS

Revolution MedicinesCA, United States
1 day ago
Salary
$204,000.00–$255,000.00 yearly
Job type
  • Full-time
Job description

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity :

The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director will support policy and process development within regulatory and cross-functionally to define a consistent RevMed approach to regulatory advice and strategy. The Director must have a thorough understanding of and be highly experienced in oncology drug development, applicable regulations, and current health authority thinking, and have strong leadership and relationship-building ability.

  • Deliver sound regulatory strategy to program teams
  • Motivate, mentor and develop direct reports
  • Ensure drug development programs are fully resourced for applicable stages of development Anticipate upcoming work; ensure robust and effective regulatory strategy support.
  • Ensure regulatory strategy takes account of competitive developments, expert feedback, and that advice is aligned with company goals and objectives
  • Ensure regulatory advice, policy and decision-making is consistent across programs and that learnings from one program are fully considered in all other programs.
  • Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.

Required Skills, Experience and Education :

  • Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical / biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.
  • Demonstrated success in leading regulatory submissions globally
  • Direct experience with oncology drug development.
  • Experienced in representing Regulatory on cross functional teams and presenting to senior management. Excellent communicator.
  • Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
  • Preferred Skills :

  • An advanced degree is desirable.
  • Experience with combination studies, multiple expansion cohort, basket or umbrella and master protocols highly preferred.
  • Prior NDA experience is highly preferred.
  • The base salary range for this full-time position is $204,000 to $255,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

    Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

    Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity / expression, national origin / ancestry, age, disability, marital status, medical condition, and veteran status.

    Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [email protected].

    LI-Hybrid #LI-SH1