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Regulatory affairs manager Jobs in Cary, NC

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Regulatory affairs manager • cary nc

Last updated: 3 hours ago
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Regulatory Affairs Senior Manager

Regulatory Affairs Senior Manager

Loparex LLCCary, NC, US
Full-time
Loparex is the world's leading developer and producer of specialty paper and film release liners.We partner with customers around the globe and enable sustainable performance through our in-dep...Show moreLast updated: 30+ days ago
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Associate Regulatory Affairs Manager

Associate Regulatory Affairs Manager

cGxPServeRaleigh, NC, United States
Full-time
Quick Apply
Responsibilities : The Associate Regulatory Affairs Manager will support the development, review, and submission of regulatory documents for medical device a...Show moreLast updated: 8 hours ago
Intern, Regulatory Affairs, US Global Rare Diseases

Intern, Regulatory Affairs, US Global Rare Diseases

CHIESI USACary, NC
Full-time
We want to be recognized as an international group focused on research, able to develop and commercialize innovative therapeutic solutions to improve the quality of people's lives who suffer from r...Show moreLast updated: 30+ days ago
  • Promoted
Healthcare Regulatory Attorney

Healthcare Regulatory Attorney

Ave Staffing Legal SpecialistsRaleigh, NC, US
Full-time
FDA & Healthcare Regulatory Attorney -.FDA & Healthcare Regulatory Attorney.North Carolina-based business law firm.Join a dynamic team of 50 legal professionals committed to providing excep...Show moreLast updated: 30+ days ago
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Global Regulatory Affairs Manager

Global Regulatory Affairs Manager

Katalyst HealthCares and Life SciencesCary, NC, US
Full-time
The Global RA Manager supports the Global Regulatory Teams in the translation of regulatory requirements into practical application to ensure the success of pre-approval drug development programs.S...Show moreLast updated: 30+ days ago
  • New!
Associate Regulatory Affairs Manager

Associate Regulatory Affairs Manager

Katalyst HealthCares & Life SciencesRaleigh, NC
Full-time
The Associate Regulatory Affairs Manager will support the development, review, and submission of regulatory documents for medical device and IVD products. This role will assist in managing regulator...Show moreLast updated: 10 hours ago
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Regulatory Engineer

Regulatory Engineer

OnLogicCary, NC, US
Full-time
As a member of the Regulatory Engineering Team, you will be responsible for ensuring customer applications and hardware developments meet the regulatory standards of industrial, medical, and comput...Show moreLast updated: 30+ days ago
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senior regulatory consultant

senior regulatory consultant

Syneos Health / inVentiv Health Commercial LLCMorrisville, NC, United States
Full-time
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into ...Show moreLast updated: 7 days ago
Regulatory Writers

Regulatory Writers

AlphanumericRaleigh, NC, US
Full-time
Regulatory Affairs / Medical Writing.Regulatory Medical Writer - NDA Submission Support.Location : Remote | Contract (Immediate Need). We are supporting a potential new client with an.We are seeking ...Show moreLast updated: 26 days ago
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Associate Regulatory Affairs Manager

Associate Regulatory Affairs Manager

Katalyst Healthcares & Life SciencesRaleigh, NC
Full-time
The Associate Regulatory Affairs Manager will support the development, review, and submission of regulatory documents for medical device and IVD products. This role will assist in managing regulator...Show moreLast updated: 3 hours ago
  • Promoted
Senior Healthcare Regulatory Attorney

Senior Healthcare Regulatory Attorney

Vivo HealthStaffCary, NC, US
Permanent
Vivo HealthStaff is recruiting for a Senior Healthcare Regulatory Attorney in North Carolina (Charlotte, Raleigh) South Carolina (Charleston, Columbia, Greenville, Spartanburg) GA (Atlanta), or Was...Show moreLast updated: 8 days ago
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Manager, Government Affairs

Manager, Government Affairs

Macquarie Global ServicesCary, NC, United States
Full-time
Join Macquarie's Government Affairs team Engage closely with government and related stakeholders in a dynamic global environment. Drive commercial outcomes and advance public policy objectives.About...Show moreLast updated: 3 days ago
Senior Manager, Medical Affairs Strategy

Senior Manager, Medical Affairs Strategy

Merz TherapeuticsRaleigh, NC , US
Full-time
Based in the Raleigh, North Carolina Corporate office - Hybrid.Step into the future with us at Merz Therapeutics, where our family roots meet a bold new vision. Together, we’re embarking on a transf...Show moreLast updated: 6 days ago
Senior Manager, Medical Affairs Strategy

Senior Manager, Medical Affairs Strategy

Merz Pharmaceuticals LLCRaleigh, US
Full-time
Based in the Raleigh, North Carolina Corporate office - Hybrid Step into the future with us at Merz Therapeutics, where our family roots meet a bold new vision. Together, we're embarking on a transf...Show moreLast updated: 4 days ago
Sr Regulatory Affairs Strategy Specialist

Sr Regulatory Affairs Strategy Specialist

BDDavis Drive,Durham,USA NC
Full-time
BD is one of the largest global medical technology companies in the world.Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—fro...Show moreLast updated: 22 days ago
Clinical Affairs Scientist

Clinical Affairs Scientist

AgilentDurham Area, NC, US
Remote
Full-time
We are searching for an experienced Clinical Affairs Scientist (CAS) to work within the medical diagnostic field as a key member of the Organization of Chief Medical Officer (OCMO) Global Clinical ...Show moreLast updated: 29 days ago
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Regulatory Affairs Specialist

Regulatory Affairs Specialist

VirtualVocationsRaleigh, North Carolina, United States
Full-time
A company is looking for a Regulatory Affairs Specialist II.Key Responsibilities Leads regulatory submissions to obtain and maintain approvals for medical devices Provides regulatory guidance an...Show moreLast updated: 16 days ago
Regulatory Affairs Team Lead

Regulatory Affairs Team Lead

TeleflexRaleigh, NC, United States
Full-time
Expected Travel : Up to 25%Requisition ID : 12025About Teleflex IncorporatedAs a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people...Show moreLast updated: 2 days ago
Regulatory Affairs Specialist - Contractor

Regulatory Affairs Specialist - Contractor

Align TechnologyMorrisville, North Carolina
Full-time
The Regulatory Affairs Specialist- Contractor will assist or lead a variety of regulatory tasks in support of global regulatory strategy, regulatory assessment for modified product, regulatory fili...Show moreLast updated: 30+ days ago
Government Affairs Manager

Government Affairs Manager

JTIRaleigh, North Carolina, US,
Full-time
We’re JTI, Japan Tobacco International and.We think that the possibilities are limitless when you’re free to choose.In fact, we’ve spent the last 20 years innovating, creating new and better produc...Show moreLast updated: 30+ days ago
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Regulatory Affairs Senior Manager

Regulatory Affairs Senior Manager

Loparex LLCCary, NC, US
30+ days ago
Job type
  • Full-time
Job description

Job Description

Job Description

Loparex is the world's leading developer and producer of specialty paper and film release liners. We partner with customers around the globe and enable sustainable performance through our in-depth material science expertise and industry-leading technology portfolio. The company is headquartered in Cary, North Carolina, U.S.A. and has three manufacturing sites in North America (Hammond, WI; Iowa City; IA; Malvern, PA), two manufacturing sites in Europe (Apeldoorn, The Netherlands; Forchheim, Germany), one manufacturing site in India (Silvassa) and one manufacturing site in China (Guangzhou).

We are excited to share we are looking for an experienced Regulatory Affairs Senior Manager to join our team!

In this role, the Regulatory Affairs Senior Manager is responsible for managing the Regulatory Affairs Team globally, providing coaching and developing the team acting as a Player Coach.

PRIMARY JOB DUTIES AND RESPONSIBILITIES :

  • Regulatory Policy : Together with the VP Technology, define and implement Loparex's regulatory affairs policy globally
  • Regulatory Strategy : Develop and implement regulatory strategies that enable the delivery of product innovations and growth of base business
  • Regulatory compliance : Ensure all products placed on market meet relevant national and international regulatory requirements
  • Regulatory Submissions : Independently manage in a timely manner all regulatory submissions including a.o DMF and FDA submissions
  • Regulatory Intelligence : Monitor, collect and interpret regulatory issues, legislations, trends or insight that will impact the business and communicate regulatory risk assessments to the relevant global teams
  • Supplier Data : Develop and maintain process for supplier regulatory data collection and adoption of intelligence authoring processes for compliance statements
  • Customer and Product Regulatory Statements : Develop strategy to quickly respond to customer regulatory requests and provide rapid and accurate customer feedback including product compliance statements
  • Communication and Coordination : Collaborate with multi-functional team including R&D, Marketing, EHS, QA and Sales

JOB SKILLS, EXPERIENCE, AND KNOWLEDGE REQUIREMENTS :

  • Bachelor's Degree in Chemistry or Environmental Science
  • Minimum 8 years regulatory affairs experience with at least 3 years of people management within regulatory affairs
  • Good knowledge of available Intelligent Authoring and Compliance Management software required
  • Knowledge of flexible packaging or paper industries preferred
  • Excellent organizational skills
  • Excellent cross functional and cross cultural communication skills
  • Fluent in English with German language an advantage
  • Global experience preferred
  • BENEFITS :

  • Medical, Dental, and Vision Insurance
  • Health savings account with generous annual employer contribution
  • Fitness reimbursement program
  • Development and career growth opportunities
  • Competitive 401(k) matching program
  • We are an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other category protected by applicable law.