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Regulatory affairs Jobs in Raleigh, NC

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Regulatory affairs • raleigh nc

Last updated: 7 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
Regulatory Affairs - Labeling Strategy, Senior Manager

Regulatory Affairs - Labeling Strategy, Senior Manager

Piper CompaniesRaleigh, NC
Full-time
Senior Manager for Regulatory Affairs Labeling Strategy.In this role, you will lead labeling strategies, ensuring compliance with regulatory requirements while supporting product development and co...Show moreLast updated: 30+ days ago
  • Promoted
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
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: 3 days ago
Insurance Solutions Consultant (Regulatory Compliance).

Insurance Solutions Consultant (Regulatory Compliance).

Schuback Search AssociatesRaleigh, NC
Permanent
Insurance Solutions Consultant.We are a fast growing SaaS company in the insurance industry, providing innovative document workflow automation solutions to insurance carriers that streamline critic...Show moreLast updated: 3 days ago
  • Promoted
  • New!
Regulatory Affairs Coordinator

Regulatory Affairs Coordinator

VirtualVocationsRaleigh, North Carolina, United States
Full-time
A company is looking for a Regulatory and Sustainability Affairs Coordinator.Key Responsibilities : Collect and evaluate raw material documentation for ingredient safety and regulatory compliance ...Show moreLast updated: 17 hours ago
Regulatory Affairs Senior Manager

Regulatory Affairs Senior Manager

Loparex LLCCary, NC, USA
Full-time
Quick Apply
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 m...Show moreLast updated: 30+ days ago
  • Promoted
Global Regulatory Lead (Raleigh, NC)

Global Regulatory Lead (Raleigh, NC)

UCBRaleigh, NC, US
Full-time
Global Regulatory Affairs team, based in any of our Brussels (Belgium), Slough (UK) or Atlanta or Raleigh (US) offices.The Global Regulatory Affairs Leader provides regulatory leadership tailored t...Show moreLast updated: 9 days ago
Medical Affairs Clinician - Los Angeles

Medical Affairs Clinician - Los Angeles

Merz AestheticsRaleigh, NC, US
Full-time
The Medical Affairs Clinician acts as an aesthetic product expert for advanced hands-on training on Merz Aesthetics' injection and device aesthetic portfolio. Provide on and off-label advanced injec...Show moreLast updated: 3 days ago
Insurance Solutions Consultant (Regulatory Compliance)

Insurance Solutions Consultant (Regulatory Compliance)

bizjobz LLCRaleigh, NC
Full-time
Insurance Solutions Consultant.We are a fast growing SaaS company in the insurance industry, providing innovative document workflow automation solutions to insurance carriers that streamline critic...Show moreLast updated: 3 days ago
Principal Regulatory Strategist (CRO / Pharma Industry) - Remote

Principal Regulatory Strategist (CRO / Pharma Industry) - Remote

MMSRaleigh, NC, US
Remote
Full-time
Quick Apply
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organ...Show moreLast updated: 11 days ago
  • Promoted
  • New!
Regulatory Associate

Regulatory Associate

Invenia GroupRaleigh, NC, United States
Full-time
Invenia Group has partnered with a fast-growing, award-winning pharmaceutical company, looking to hire a Regulatory Associate to its team of experts to be based in Raleigh, 3 days per week.As a Reg...Show moreLast updated: 7 hours ago
  • Promoted
Regulatory Senior Program Manager

Regulatory Senior Program Manager

Aerogen LtdRaleigh, NC, US
Full-time
Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug / biologic and device combination that will transform the standard of care for acut...Show moreLast updated: 30+ days ago
Insurance Solutions Consultant (Regulatory Compliance)

Insurance Solutions Consultant (Regulatory Compliance)

Professional Recruiting Consultants, Inc.Raleigh , NC
Permanent
Insurance Solutions Consultant.We are a fast growing SaaS company in the insurance industry, providing innovative document workflow automation solutions to insurance carriers that streamline critic...Show moreLast updated: 3 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
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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  • New!
Business Analyst in regulatory reporting

Business Analyst in regulatory reporting

E-SolutionsCary, NC, US
Full-time
Below is the detailed JD for the requirement : .Business Analyst in regulatory reporting.Experience in Business Functional Analysis and Financial Services (in the Banking domain-Reg reporting).Minimu...Show moreLast updated: 16 hours ago
  • Promoted
Axiom Software Engineer- Regulatory Reporting (Hybrid)

Axiom Software Engineer- Regulatory Reporting (Hybrid)

First Citizens BankRaleigh, NC, US
Full-time
This is a hybrid role, with the expectation that time working will regularly take place inside and outside of a company office. We are seeking a highly experienced and technically proficient profess...Show moreLast updated: 10 days ago
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Intern, Regulatory Affairs, US Global Rare Diseases

Intern, Regulatory Affairs, US Global Rare Diseases

CHIESI USACary, NC
30+ days ago
Job type
  • Full-time
Job description

Company Mission :

  • 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 rare disease.
  • We intend to maintain a high-quality entrepreneurial team, characterized by a spirit of cooperation and self-confidence.
  • Our goal is to combine commitment to results with integrity while operating responsibly from both a social and environmental point of view.

Job Purpose : The Chiesi - Regulatory Affairs internship will be an immersive experience that will include exposure to several regulatory projects directly related to the development of drugs and biologics. Education and training may include some FDA and Industry Sponsored lectures, but the focus will be a mainly on-the-job training experience.

Summary of Key Responsibilities :

Global Regulatory Affairs Project Coordination :

  • Coordinating aspects of communication and activities related to Global Rare Disease project execution
  • Prepare agendas and attend internal meetings for internal initiatives and development plans for specific products.
  • Coordinate authoring and review of U.S. regulatory submissions
  • Quality Assurance and Quality Control review of U.S. regulatory submissions and internal documents
  • Maintenance of Global Rare Disease Regulatory Affairs trackers, databases, and other internal resources.
  • Additional Responsibilities :

  • Support Regulatory Intelligence Activities
  • 100%

    Required Skills :

  • A minimum of a Bachelor’s degree in a scientific discipline is required.
  • Strong organizational and planning skills
  • Strong knowledge of MS Office Suite - Word, Excel, PowerPoint
  • Microsoft Project skills a plus
  • Exceptional communication in English - verbal and written
  • Detail oriented
  • Project coordination experience an asset
  • Must be detail- and goal-oriented, quality conscientious, and results-oriented.
  • An ability to manage changing priorities, multiple tasks, and communicate impact to project teams is required.
  • Key Competencies :

    Organizational Ability – Attention to timelines and deadlines. An ability to review and prioritize organizational commitments to maximize productivity across functional groups

    Attention to Detail – Is thorough when performing work; conscientious about attending to detail; few errors in work performed; uses logical thinking that is well organized and methodical.

    High Productivity – Produces consistent, high quality and quantity of outputs and meaningful results that contribute to the agency mission and strategic goal. Is efficient in producing results that are delivered on time or before. Able to multi-task productively because is well-organized; applies time management processes and procedures effectively

    Teamwork / Collaboration – Works toward common goals by supporting, encouraging, and sharing information with colleagues, both internal and external

    Communication — Speaks, writes, listens, and presents information in a logical and articulate manner appropriate for the audience.