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Regulatory affairs associate Jobs in Durham, NC

Last updated: 1 day ago
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Associate Director Regulatory Affairs

Associate Director Regulatory Affairs

Proclinical StaffingDurham, NC, United States
Permanent
Associate Director, Regulatory Affairs – Permanent – Georgia or North Carolina.Proclinical is seeking an Associate Director, Regulatory Affairs for a successful and growing global biopharmaceutical...Show moreLast updated: 3 days ago
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Regulatory Affairs Internship

Regulatory Affairs Internship

Sipcam AgroDurham, NC, United States
Internship
Regulatory Affairs Intern Job Description : Sipcam Agro USA is based in Durham, NC.Our company is recognized worldwide for formulation and manufacturing expertise in the crop protection industry...Show moreLast updated: 1 day ago
Global Corporate Affairs Associate Director, Alzheimer’s disease

Global Corporate Affairs Associate Director, Alzheimer’s disease

LillyDurham, North Carolina, United States of America
Full-time
We’re looking for people who are determined to make life better for people around the world.The Associate Director of Corporate Affairs (CA) for Alzheimer's disease will play a crucial role in supp...Show moreLast updated: 30+ days ago
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Director, Regulatory Advertising and Promotion Policy

Director, Regulatory Advertising and Promotion Policy

GlaxoSmithKline, plcDurham, NC, United States
Full-time
As the Director, Regulatory Advertising & Promotion Policy, you will be responsible for leading assigned products providing sound regulatory advice for advertising and promotion of prescription dru...Show moreLast updated: 3 days ago
Executive Director, Legislative and Regulatory Policy

Executive Director, Legislative and Regulatory Policy

001_BCBSA Blue Cross and Blue Shield AssociationUS North Carolina Remote
Remote
Full-time
Senior leader to advance BCBSA’s legislative and regulatory policy solutions and market positioning in Medicare, Medicaid, Duals, and Children's Health Insurance Program, impacting the tens of mill...Show moreLast updated: 30+ days ago
Director, Regulatory Affairs Specialty, HIV

Director, Regulatory Affairs Specialty, HIV

1925 GlaxoSmithKline LLCDurham Blackwell Street
Full-time
Ensure the development of appropriate regulatory strategy(ies) and their execution for for early and / or late stage HIV or other assigned asset(s) consistent with Medicines Development Strategy / Inte...Show moreLast updated: 30+ days ago
Associate Director, Student Affairs

Associate Director, Student Affairs

Duke HealthDurham, NC, US
Associate Director, Student Affairs.Work Arrangement : Requisition Number : 245443 Regular or Temporary : Regular Location : . Personnel Area : UNIVERSITY Date : Jul 10, 2024.Duke University was created in...Show moreLast updated: 30+ days ago
Legal and External Affairs Administrative Assistant

Legal and External Affairs Administrative Assistant

North Carolina Medical BoardNorth Carolina, US
Legal and External Affairs Administrative Assistant.This position is responsible for providing administrative support to the Boards Chief Legal Officer, legal staff and external affairs staff.This ...Show moreLast updated: 30+ days ago
Sr Dir, Business Development, Medical Affairs

Sr Dir, Business Development, Medical Affairs

IQVIADurham, North Carolina, US
Full-time
Establish and manage an effective business development program to maximize organizational growth.Direct business development activities to achieve sales and new business goals from identification t...Show moreLast updated: 30+ days ago
Senior Regulatory Implementation & Assurance Analyst

Senior Regulatory Implementation & Assurance Analyst

Highmark HealthNC, Working at Home, N Carolina
$124,800.00 yearly
Full-time
This job is responsible for leading large projects and initiatives related to the risk case management and intake activities of Highmark Health in support of a broad range of frameworks and oversig...Show moreLast updated: 30+ days ago
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Associate Director, Student Affairs

Associate Director, Student Affairs

Duke UniversityDurham, NC, United States
Full-time
Duke University was created in 1924 through an indenture of trust by James Buchanan Duke.Today, Duke is regarded as one of America's leading research universities. Located in Durham, North Carolina,...Show moreLast updated: 29 days ago
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Director of External Affairs

Director of External Affairs

InsideHigherEdChapel Hill, North Carolina
Full-time +2
Kenan Institute of Private Ent-331600.Public Relations / Communications / Marketing.A global higher education leader in innovative teaching, research and public service, the. University of North Carolin...Show moreLast updated: 4 days ago
Research Regulatory Manager

Research Regulatory Manager

The University of North Carolina at Chapel HillChapel Hill, NC, US
Under the guidance of the Director, Regulatory Operations, the Clinical assists with oversight of regulatory operations for the UNC Lineberger (LCCC) Clinical Trials Office (CTO).Serves as a key me...Show moreLast updated: 30+ days ago
Associate / Director of Regulatory Affairs (remote US or Canada)

Associate / Director of Regulatory Affairs (remote US or Canada)

ParexelRemote, North Carolina, United States
Remote
When our values align, there's no limit to what we can achieve.Exciting opportunity to join Parexel as an Associate / Director of Regulatory Affairs!. As an Associate / Director of Regulatory Affairs, y...Show moreLast updated: 30+ days ago
Senior Manager, CMC Facilities Regulatory Affairs

Senior Manager, CMC Facilities Regulatory Affairs

9627 Corixa CorporationDurham Blackwell Street
Full-time
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change...Show moreLast updated: 30+ days ago
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Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager

LifelancerDurham, NC, US
$128,000.00–$176,000.00 yearly
Full-time
Senior Regulatory Affairs Manager.Now hiring! Senior Regulatory Affairs Manager.Research Triangle Park, NC or Remote US.We are looking for a Senior Regulatory Affairs Manager to join our Agricultur...Show moreLast updated: 1 day ago
Reg Affairs Manager - Medical Devices, Neuroscience

Reg Affairs Manager - Medical Devices, Neuroscience

Thermo Fisher ScientificNorth Carolina, United States of America
Remote
Full-time
Understand and interpret US and global regulatory requirements for medical devices, in vitro diagnostics (IVD), and combination products. Author pre-submissions, breakthrough device designation requ...Show moreLast updated: 30+ days ago
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Political Affairs Internship

Political Affairs Internship

The Borgen ProjectChapel Hill, North Carolina, US
Part-time +1
Are you passionate about making a difference in the world? Look no further!.Scroll down the page to see all associated job requirements, and any responsibilities successful candidates can expect.Th...Show moreLast updated: 4 days ago
Medical Director (Medical Affairs)

Medical Director (Medical Affairs)

CVS HealthWork from home, NC, US
Remote
Full-time
Bring your heart to CVS Health.Every one of us at CVS Health shares a single, clear purpose : Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced...Show moreLast updated: 30+ days ago
Regulatory Specialist Internship

Regulatory Specialist Internship

UPLNC, US
NSE : UPL & BSE : 512070, LSE : UPLL) is a global provider of sustainable agriculture products and solutions, with annual revenue exceeding $6bn. Through OpenAg®, UPL is focused on accelerating progres...Show moreLast updated: 30+ days ago
Associate Director Regulatory Affairs

Associate Director Regulatory Affairs

Proclinical StaffingDurham, NC, United States
3 days ago
Job type
  • Permanent
Job description

Associate Director, Regulatory Affairs – Permanent – Georgia or North Carolina

Proclinical is seeking an Associate Director, Regulatory Affairs for a successful and growing global biopharmaceutical company with locations in Georgia and North Carolina.

Primary Responsibilities :

In this role, you will be responsible for all regulatory activities related to product development and marketing authorizations in the US and is the primary contact point within the company for any regulatory issues with the product and with designated health authorities. You will successfully collaborate & partner with members of the US Regulatory Affairs department within the Neurology therapeutic area.

The position can be based in Georgia or North Carolina in a hybrid work schedule.

Skills & Requirements :

  • Minimum of a Bachelor’s degree : Master’s degree preferred.
  • A minimum of 5+ years of progressive experience in the Pharmaceutical, Biotechnology and / or CRO industry is required.
  • 10 years pharmaceutical experience in Regulatory Affairs preferred.
  • Demonstrated experience building effective partnerships :
  • Identifies opportunities and takes actions to build effective relationships within and across teams with appropriate use of interpersonal skills and sensitivity to diverse cultures comprising the global work environment.

The Associate Director, Regulatory Affairs will :

  • Develops and implements the regional regulatory strategy and plan consistent with the business objectives, inputting regional expertise into the global regulatory strategy and global planning in line with the Global Regulatory Lead.
  • Responsible for ensuring that the regional regulatory strategy for the specific product(s), have been negotiated (if appropriate) with the regional health authorities and that the regulatory risks have been identified and mitigated.
  • Deliver regulatory submissions in line with the applicable regulations, directives and guidelines, and in line with agreed strategies and timelines.
  • Assist in development of regulatory standards, efficient processes and SOPs.
  • If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or [email protected] .

    Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

    Proclinical Staffing is an equal opportunity employer.