Talent.com
Senior Director of Regulatory Affairs
Senior Director of Regulatory AffairsVirtualVocations • Hamilton, New Jersey, United States
Senior Director of Regulatory Affairs

Senior Director of Regulatory Affairs

VirtualVocations • Hamilton, New Jersey, United States
30+ days ago
Job type
  • Full-time
Job description

A company is looking for a Senior Director, Regulatory Affairs.

Key Responsibilities

Represent regulatory on cross-functional teams and provide leadership for regulatory deliverables

Lead planning and support the development of global regulatory submission documents

Serve as primary contact with Health Authorities and maintain expert knowledge in regulations

Required Qualifications

Bachelor's degree with a minimum of 10 years of experience in Regulatory Affairs

Demonstrated successful interactions with FDA and other Health Authorities

Expert understanding of global drug development principles and regulatory requirements

Experience in preparing regulatory filings, including IND / CTAs and briefing documents

Strong project management skills and ability to work in a dynamic environment

Create a job alert for this search

Director Regulatory • Hamilton, New Jersey, United States

Related jobs
Regulatory Affairs Associate Director

Regulatory Affairs Associate Director

VirtualVocations • Elizabeth, New Jersey, United States
Full-time
A company is looking for an Associate Director, Regulatory Affairs - Contract.Key Responsibilities Serve as the regulatory representative for drug development project teams, contributing to regul...Show more
Last updated: 1 day ago • Promoted
Senior Director of Governance

Senior Director of Governance

VirtualVocations • Hamilton, New Jersey, United States
Full-time
A company is looking for a Senior Director of Governance to lead member-facing policies and procedures that align with organizational values. Key Responsibilities Ensure alignment of policies and ...Show more
Last updated: 30+ days ago • Promoted
Director, RA Global Regulatory Strategy

Director, RA Global Regulatory Strategy

AbbVie • Florham Park, NJ, US
Full-time
Director, Regulatory Affairs Global Regulatory Strategy.AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical...Show more
Last updated: 30+ days ago • Promoted
Director, Global Medical and Promotional Regulatory Affairs

Director, Global Medical and Promotional Regulatory Affairs

Jazz Pharmaceuticals • Philadelphia, PA, United States
Full-time
If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and ...Show more
Last updated: 30+ days ago • Promoted
Principal Specialist, Regulatory Affairs

Principal Specialist, Regulatory Affairs

ImmunityBio • Summit, NJ, United States
Full-time
NASDAQ : IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling ...Show more
Last updated: 30+ days ago • Promoted
Director / Senior Director Regulatory Strategist

Director / Senior Director Regulatory Strategist

Sun Pharma • Princeton, NJ, US
Full-time
Come Work For Us - Investing In You As A Sun Pharma Employee!.Medical, Dental, Vision Benefits.Health Savings Account (HSA), Flexible Spending Account (FSA). Telehealth and Behavior Health Services....Show more
Last updated: 30+ days ago • Promoted
Director, Regulatory Affairs

Director, Regulatory Affairs

LVMH Perfumes & Cosmetics • East Brunswick, NJ, US
Full-time
LVMH's Beauty activities benefit from exceptional dynamism that relies on both the longevity and development of key lines, and on the boldness of new creations. All are driven by the same values : a ...Show more
Last updated: 30+ days ago • Promoted
Executive Director of Regulatory Ad / Promo

Executive Director of Regulatory Ad / Promo

EPM Scientific • Bridgewater, NJ, United States
Full-time
Executive Director of Regulatory Affairs Ad / Promo.A global health care company, dedicated to improving people's lives through innovative solutions specialized in pharmaceuticals, medical devices, a...Show more
Last updated: 1 day ago • Promoted
Director of Regulatory Affairs

Director of Regulatory Affairs

VirtualVocations • Newark, New Jersey, United States
Full-time
A company is looking for a Director, Regulatory Project Management to lead the end-to-end project management of a New Drug Application (NDA) submission. Key Responsibilities Develop and maintain a...Show more
Last updated: 30+ days ago • Promoted
US Regulatory Affairs Manager

US Regulatory Affairs Manager

VirtualVocations • Newark, New Jersey, United States
Full-time
A company is looking for a US Regulatory Lead.Key Responsibilities Support the Global Regulatory Team in US Regulatory Activities, including IND development and submission Act as the primary poi...Show more
Last updated: 1 day ago • Promoted
Associate Director, Regulatory Policy

Associate Director, Regulatory Policy

Bristol Myers Squibb • Princeton, NJ, US
Full-time
Associate Director Regulatory Policy.Those aren't words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens ever...Show more
Last updated: 30+ days ago • Promoted
Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist

VirtualVocations • Elizabeth, New Jersey, United States
Full-time
A company is looking for a Principal Regulatory Affairs Specialist.Key Responsibilities Serve as the primary liaison between the Product Stewardship team and various stakeholders regarding produc...Show more
Last updated: 30+ days ago • Promoted
Senior Director, Regulatory Affairs CMC Policy and Advocacy

Senior Director, Regulatory Affairs CMC Policy and Advocacy

Alnylam Pharmaceuticals • Philadelphia, PA, US
Full-time
Senior Director, Regulatory Affairs CMC Policy And Advocacy.The Senior Director, Regulatory Affairs CMC Policy and Advocacy will lead the development and implementation of global regulatory advocac...Show more
Last updated: 18 days ago • Promoted
Director, Global Regulatory Affairs - Global Labeling Strategy

Director, Global Regulatory Affairs - Global Labeling Strategy

Sanofi • Morristown, NJ, US
Full-time
Director, Global Regulatory Affairs - Global Labeling Strategy.Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients ...Show more
Last updated: 30+ days ago • Promoted
Global Regulatory Lead

Global Regulatory Lead

Staffing • Madison, NJ, US
Full-time
Estimate Start Date July 7th At LEO Pharma, our mission transcends the conventional.We're on an ambitious path to become the leaders in medical dermatology worldwide. If you're ready to make a diffe...Show more
Last updated: 30+ days ago • Promoted
Senior Director, Regulatory Affairs

Senior Director, Regulatory Affairs

Sun Pharma • Princeton, NJ, US
Full-time
Come Work for Us - Investing in You as a Sun Pharma Employee!.Medical, Dental, Vision Benefits.Health Savings Account (HSA), Flexible Spending Account (FSA). Telehealth and Behavior Health Services....Show more
Last updated: 30+ days ago • Promoted
Associate Director, Global Regulatory Affairs, Strategy

Associate Director, Global Regulatory Affairs, Strategy

Genmab • Princeton, NJ, US
Full-time
Associate Director, Global Regulatory Affairs, Strategy.At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-...Show more
Last updated: 30+ days ago • Promoted
Senior Vice President, Regulatory Affairs

Senior Vice President, Regulatory Affairs

Rocket Pharmaceuticals • Cranbury Township, NJ, United States
Full-time
Work at ROCKET PHARMA and help cure rare diseases!.Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases....Show more
Last updated: 2 days ago • Promoted