Talent.com
serp_jobs.error_messages.no_longer_accepting
Regulatory Submissions Manager

Regulatory Submissions Manager

VirtualVocationsNewark, New Jersey, United States
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

A company is looking for a Regulatory Submissions Manager to support high-priority regulatory activities in the biopharma sector.

Key Responsibilities

Lead and coordinate the preparation, formatting, and submission of regulatory documents for INDs / CTAs and NDA amendments

Manage document lifecycle and submission tracking using Veeva RIM

Collaborate with cross-functional teams to ensure timely and accurate submissions

Required Qualifications

Bachelor's degree in life sciences or related field; advanced degree preferred

Minimum 5 years of experience in regulatory operations or submission management in the biotech / pharma industry

Proven experience with IND and NDA submissions

High proficiency in Veeva RIM

Strong knowledge of eCTD structure and FDA / EMA submission requirements

serp_jobs.job_alerts.create_a_job

Regulatory Manager • Newark, New Jersey, United States

Job_description.internal_linking.related_jobs
  • serp_jobs.job_card.promoted
Regulatory and Medical Affairs - Project Manager, US Field Medical Capabilities

Regulatory and Medical Affairs - Project Manager, US Field Medical Capabilities

Tech DigitalLawrence Township, NJ, US
serp_jobs.job_card.full_time
Senior Manager / Project Manager, Global Field Medical Excellence.At Client, we are inspired by a single vision transforming patients' lives through science.serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Regulatory Affairs Director - Oncology

Regulatory Affairs Director - Oncology

AstraZenecaNew York, NY, US
serp_jobs.job_card.full_time
Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines?.At AstraZeneca, ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Regulatory Affairs Specialist II

Regulatory Affairs Specialist II

Katalyst Healthcares & Life SciencesEdison, NJ, US
serp_jobs.job_card.full_time
Responsibilities : This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U. Europe, support of international product registrations ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs

Eikon TherapeuticsJersey City, NJ, US
serp_jobs.job_card.full_time
Senior Manager, Regulatory Affairs.Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology t...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Manager, Global Scientific & Regulatory Affairs

Manager, Global Scientific & Regulatory Affairs

IngredionBound Brook, NJ, US
serp_jobs.job_card.full_time
Ingredion is seeking a knowledgeable and motivated Regulatory Affairs Manager to support innovation initiatives, assist in securing ingredient approvals, and help ensure regulatory compliance acros...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Regulatory & Medical Affairs - Project Manager

Regulatory & Medical Affairs - Project Manager

Tech DigitalPrinceton, NJ, US
serp_jobs.job_card.full_time
Leads the launch project teams / workstreams to execute on assigned complex launch(es) across therapeutic areas using the established Client launch methodology and centralized tool.Works with the Bra...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Regulatory Stewardship Specialist

Regulatory Stewardship Specialist

Sika USALyndhurst, NJ, US
serp_jobs.job_card.full_time
Regulatory Stewardship Specialist.With more than 100 years of experience, Sika is a worldwide innovation and sustainability leader in the development and production of systems and products for comm...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
RegulatoryAffairsSeniorManager

RegulatoryAffairsSeniorManager

Katalyst Healthcares & Life SciencesTarrytown, NY, US
serp_jobs.job_card.full_time
Responsibilities : US Agent for all products, responsible for communication between the FDA and manufacturing sites.Communicate and follow-up status with FDA for any Chemistry, Bioequivalence and Pa...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Manager, Regulatory Program Manager - Oncology

Manager, Regulatory Program Manager - Oncology

J&J Family of CompaniesRaritan, NJ, US
serp_jobs.job_card.full_time
Manager, Regulatory Program Manager - Oncology.Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.Visionaries like you wor...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Senior Manager, Regulatory Affairs Strategy - Oncology

Senior Manager, Regulatory Affairs Strategy - Oncology

RegeneronTarrytown, NY, US
serp_jobs.job_card.full_time
Senior Manager, Regulatory Affairs.The Senior Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs rel...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Senior Manager, Global Regulatory Affairs, Strategy

Senior Manager, Global Regulatory Affairs, Strategy

GenmabPrinceton, NJ, US
serp_jobs.job_card.full_time
Senior Manager Regulatory Affairs Strategy.Genmab is looking for a Senior Manager, Global Regulatory Affairs, Regulatory Strategy to be a part of our Global Regulatory Affairs organization.In this ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
  • serp_jobs.job_card.new
Sr.RegulatoryAffairs Manager (Tarrytown)

Sr.RegulatoryAffairs Manager (Tarrytown)

Katalyst HealthCares & Life SciencesTarrytown, NY, United States
serp_jobs.job_card.full_time
Manager, Regulatory Affairs for Getinge's Endovascular product area within our global Acute Care Therapy business area will be responsible for partnering with R&D and Marketing as well as other cro...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_hour
Regulatory Guidance Manager NYC

Regulatory Guidance Manager NYC

AthariNew York, NY, US
serp_jobs.filters.remote
serp_jobs.job_card.full_time
serp_jobs.filters_job_card.quick_apply
The Regulatory Guidance Manager is responsible for overseeing a team of analysts and ensuring regulatory compliance by disseminating guidance to affected business units. The position will develop an...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Regulatory Operations Associate

Regulatory Operations Associate

MUFGNew York, NY, US
serp_jobs.job_card.full_time
Join Mitsubishi UFJ Financial Group.Do you want your voice heard and your actions to count? Discover your opportunity with Mitsubishi UFJ Financial Group (MUFG), one of the worlds leading financial...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Regulatory Affairs Specialist III

Regulatory Affairs Specialist III

HireTalentBound Brook, NJ, US
serp_jobs.job_card.full_time
Regulatory Affairs Specialist III.Location : Bridgewater, NJ Duration : 9 Months.Manager will consider candidates to be based in either Bridgewater, New Jersey or Cambridge, Massachusetts.Please spec...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
  • serp_jobs.job_card.new
Global Program Regulatory Manager (Remote)

Global Program Regulatory Manager (Remote)

Novartis Group CompaniesEast Hanover, New Jersey, United States
serp_jobs.filters.remote
serp_jobs.job_card.full_time
The Global Program Regulatory Manager (GPRM) works with some independence under limited supervision to provide strategic and operational regulatory direction and may support the RA global program t...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_less
  • serp_jobs.job_card.promoted
Scientific - Global Regulatory CMC Manager

Scientific - Global Regulatory CMC Manager

Tech DigitalLawrence Township, NJ, US
serp_jobs.job_card.full_time
Responsibilities will include, but are not limited to, the following : .Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority br...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Sr.RegulatoryAffairs Manager

Sr.RegulatoryAffairs Manager

Katalyst Healthcares & Life SciencesTarrytown, NY, US
serp_jobs.job_card.full_time
Manager, Regulatory Affairs for Getinge's Endovascular product area within our global Acute Care Therapy business area will be responsible for partnering with R&D and Marketing as well as other cro...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Global Regulatory Affairs Compliance and Planning, Sr. Manager

Global Regulatory Affairs Compliance and Planning, Sr. Manager

Kyowa KirinPrinceton, NJ, US
serp_jobs.job_card.full_time
Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need : oncology, nephrology, imm...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Liquidity Regulatory Reporting Lead

Liquidity Regulatory Reporting Lead

Mizuho BankNew York, NY, US
serp_jobs.job_card.full_time
VP, Liquidity Regulatory Reporting Lead.The Liquidity Regulatory Reporting is a team responsible for the daily and monthly reporting and submission of FR2052A report for US Branches of Mizuho Bank....serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30