Email Alert for
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.
Cypress HCM
San Diego, CA, United States
The role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and
Job Source: Cypress HCMPfizer
San Diego, CA, United States
Work Location Assignment:Onsite/Hybrid Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and theever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and e
Job Source: PfizerPfizer
San Diego, CA, United States
To apply for this job please sign in or create an account below. must be different from email address, first name and last name Keep me signed in Marketing Communication We'd love to send you information about Jobs and Services from Evenbreak by email. Yes please. I'd like to receive emails about jobs and services from Evenbreak I'd like to rece
Job Source: PfizerNeurocrine Biosciences
San Diego, CA, United States
Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs, but few options. What We Do: Neurocrine
Job Source: Neurocrine BiosciencesBioSpace, Inc.
San Diego, CA, United States
Job Title: Director, Regulatory Operations Location: Hybrid / Remote Position type: FLSA: Full time Exempt Department: Regulatory Affairs Strive to Bring a Profound Difference to our Patients At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of
Job Source: BioSpace, Inc.Avidity NanoMedicines
San Diego, CA, United States
Description Job Title: Director, Regulatory Operations Location: Hybrid / Remote Position type: FLSA: Full time Exempt Department: Regulatory Affairs Strive to Bring a Profound Difference to our Patients At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people's lives by del
Job Source: Avidity NanoMedicinesCharles River Laboratories
San Diego
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your ski
Job Source: Charles River LaboratoriesAvidity NanoMedicines
San Diego, CA, United States
Job Title: Director, Regulatory Operations Location: Hybrid / Remote Position type: FLSA: Full time Exempt Department: Regulatory Affairs Strive to Bring a Profound Difference to our Patients At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of
Job Source: Avidity NanoMedicinesSan Diego, CA, United States
The role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and ensure adherence to regional regulations. Close collaboration with the cross-functional Development team, external consultants, and advisors is essential to seamlessly integrate regulatory plans and strategies in alignment with overall corporate objectives.
Responsibilities:
Represent the Regulatory Affairs department in multidisciplinary product development teams
Develop and execute global regulatory strategies for expedited product development across one or more programs
Lead preparation of global product development plans, target product profiles, orphan drug designation applications, and pediatric study plans
Research regulatory precedents and emerging trends for development risks and opportunities
Oversee the global regulatory lifecycle of assigned investigational products, managing timelines and coordinating submission content
Interface with the external Regulatory Operations group for document compilation and e-submission
Serve as the primary liaison for communication with regulatory health authorities
Lead milestone development meetings and prepare the team for engagements
Review and communicate current regulatory requirements for compliance with US and international regulations
Contribute to the development and review of standard operating procedures (SOPs)
Assist in archival and maintenance of regulatory application submissions
Monitor the company's progress in meeting regulatory commitments
Requirements:
Bachelors degree in life sciences; advanced degree preferred; Regulatory Affairs Certification a plus
Strong pharmaceutical Regulatory Affairs experience with a focus on drug/biologics development
Direct experience in preparing, submitting, and managing global investigational/marketing applications in eCTD format
Experience negotiating and interfacing with US and international regulatory authorities
Product development experience in dermatology, immunology, or inflammation is a plus
In-depth knowledge of GXP/ICH guidelines and global regulations
Ability to interpret and apply complex regulatory guidance
Strong written and verbal communication, analytical, organizational, and interpersonal skills
Excellent strategic planning and cross-functional project management skills
Ability to thrive in a dynamic environment with flexibility
Compensation:
$165-225K
Email Alert for Director of Regulatory Strategy jobs in San Diego, CA, United States
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.