Top 66 Regulatory affairs Jobs in Research Triangle Park Nc

Regulatory Affairs Associate (entry level)
Grifols —Durham, NC
- Full-time
- Research
- Office
- Associate's degree
Sr. Director, Strategic Regulatory Affairs and UDI
Teleflex —Morrisville, NC
- $203,000 - $253,000 a year
- 11+ years
- Office
- Analysis skills
- Disability insurance
- Health insurance
Regulatory Affairs Manager
bioventus —Durham, NC
- Full-time
- 5 years
- Senior level
- Communication skills
Senior Manager, CMC Regulatory Affairs, Global Rare Diseases
Chiesi Farmaceutici —Cary, NC
- $121,000 - $182,000 a year
- Overtime
- Hybrid work
- 5 years
- Office
- Bachelor's degree
- Health insurance
10d
Regulatory Affairs Manager - CMC & Labeling
United Therapeutics —Research Triangle Park, NC
- Full-time
- Hybrid work
- Office
- Master's degree
- Project management
- Paid parental leave
- Employee stock purchase plan
7d
QC INVESTIGATOR
Aurobindo Pharma USA, Inc. —Durham, NC
- Full-time
- Bachelor of Science
- Mid-level
- 3 years
- Health savings account
- AD&D insurance
Associate Director or Director, CMC Regulatory Affairs
Atsena —Durham, NC
- Full-time
- Remote
- 7 years
- Writing skills
- Doctor of Philosophy
Quick Apply
US Regulatory Manager
UPL ltd —Cary, NC
- Full-time
- 5 years
- Mid-level
- Presentation skills
8d
Senior Associate, Regulatory CMC
HUMACYTE GLOBAL INC —Durham, NC
- Full-time
- Remote
- Bachelor of Science
- Writing skills
- Bachelor's degree
- Paid parental leave
- Paid holidays
Quick Apply
Associate Director, Global Regulatory Advertising and Promotion
IQVIA —Durham, NC
- $103,600 - $288,600 a year
- Full-time
- Remote
- 5 years
- Master's degree
- Bachelor's degree
- Work from home
14d
Regulatory Affairs Consultant, In Silico Modeling
Pharmatech Associates —Raleigh, NC
- Part-time
- Senior level
- Leadership
- 10 years
Staff Scientist, Global Biocompatibility
Teleflex —Morrisville, NC
- Microsoft Outlook
- Office
- 3 years
Real World Evidence - Contractor
Chiesi Farmaceutici —Cary, NC
- Temporary
- Hybrid work
- Analysis skills
- Presentation skills
- Doctor of Philosophy
- Health insurance
Head of US Crop Protection Regulatory Affairs - Research Triangle Park, NC (preferred)
BASF —Research Triangle Park, NC
- Full-time
- Hybrid work
- Bachelor of Science
- 11+ years
- Bachelor's degree
- Adoption assistance
- Parental leave
9d
Medical Science Liaison, Uncontrolled Gout - Rare Disease - VA, NC
Amgen —Raleigh, NC
- $156,998.40 - $212,409.60 a year
- Mid-level
- Bachelor's degree
- Doctor of Philosophy
- Disability insurance
- Health insurance
8d
Senior Nonclinical Regulatory Affairs Scientist
RTI International —Raleigh, NC
- $125,000 - $220,000 a year
- Full-time
- Doctor of Philosophy
- Organizational skills
- Fair chance
- Paid parental leave
- Disability insurance
1d
Associate Scientist/ Scientist/ Sr. Scientist, Pharmacometrics
Xyzagen —Pittsboro, NC
- $65,000 - $115,000 a year
- Full-time
- Bachelor of Science
- Office
- Analysis skills
- Profit sharing
- Paid holidays
Quick Apply
4d
Global Regulatory CMC Scientist (Raleigh)
UCB —Raleigh, NC
- Office
- Master's degree
- Bachelor's degree
Sr Clinical Research Associate
Veranex, Inc. —Raleigh, NC
- $98,400 - $140,690 a year
- Full-time
- Remote
- Microsoft Excel
- Microsoft Outlook
- 5 years
Quick Apply
Director of Regulatory - Biological & Traditional Fertilizers
The Mosaic Company —Durham, NC
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Master's degree
- Paid parental leave
- Paid holidays

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Regulatory Affairs Associate (entry level)

Grifols -
Durham, NC

Apply Now

Job Details

Full-time

Qualifications

Biology
Legislative impact assessment
Filing
Research
Bachelor's degree in biology
Invoice payment processing
Healthcare regulatory compliance research
Pharmaceutical company experience
Compliance documentation
CLIA regulations
Pharmacy
Chemistry
Regulatory submission editing and review
Document viewing software
Associate's degree
2 years
Adobe Acrobat
Bachelor's degree in chemistry
Entry level
FDA regulations

Full Job Description

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary:
Plasma Regulatory Affairs oversees the licensing, surveillance, and other regulatory activities associated with Source Plasma collection within the United States of America, Canada and Rest of World (ROW). This includes activities associated with US Food and Drug Administration (FDA) licensure and registration (biologics (BLA), medical device), Health Canada licensing, Clinical Laboratory Improvement Amendments (CLIA) activities, Plasma Protein Therapeutics Association (PPTA) membership and certification, COLA accreditation, state/province requirements and ROW licensing activities as applicable.

The Plasma Regulatory Affairs Associate will monitor and perform administrative activities for existing licenses in compliance with US FDA, CLIA, PPTA and COLA requirements to meet business objectives.

Primary Responsibilities:
Accurately prepare regulatory applications required by federal and other regulatory authorities, as well as industry affiliates for review prior to application submission.
Research internal documents, complete applications, and forms; prepare cover letters and summaries; assemble and format applications in a manner to facilitate the review process.
Submit and monitor application submission for timely review and acceptance with the ability to respond to regulatory agency inquiries.
Provide updates to management on the status of applications.
Escalate to management urgent and time-sensitive matters that impact regulatory compliance.
Maintain files contemporaneously for transparency and timelines.
Maintain applicable shared mailboxes, dashboards and accounts related to administrative licensing activities.
Archive and distribute applications electronically and in hardcopy.
Record the details of pertinent conversations and/or written interactions with a regulatory authority, when applicable.
Educate and inform internal customers at the corporate office and at the plasmapheresis centers regarding regulatory requirements as it pertains to licensing activities.
Provide registration and licensing documentation to stakeholders in a timely manner.
Assist with evaluation of regulatory changes for impact to the business.
Process and track all invoices to ensure prompt payment associated with licensing activities.

Additional Responsibilities:
Exhibits professional behavior with internal/external business associates, reflecting positively on the company.
Understands the quality consequences of improper job performance and is aware of potential compliance defects in their area of responsibility.
Interface with various levels and groups throughout the organization.
Manage multiple tasks with competing demands and deadlines.
Assist with department related projects, goals and/or objectives.
Perform other duties as required.

Knowledge, Skills, and Abilities:
Exhibits professional behavior with internal/external business associates, reflecting positively on the company.
Understands the quality consequences of improper job performance and is aware of potential compliance defects in their area of responsibility.
Interface with various levels and groups throughout the organization.
Manage multiple tasks with competing demands and deadlines.
Assist with department related projects, goals and/or objectives.
Perform other duties as required.
Experience with Microsoft Office.
Experience with Adobe PDF.
Experience in plasma collection, pharmaceutical industry, or a regulated field.

Education and Experience:
Bachelor's Degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology).
Preferred two (2) years related technical and/or regulatory experience in pharmaceutical or blood industry.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Occupational Demands:
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups.

#Biomatusa

#App

#LI-BA1

Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

Location: NORTH AMERICA : USA : NC-RTP: USNC0003 - RTP NC-Research Building 85

Learn more about Grifols

Apply Now

Refine Your Search

regulatory affairs jobs in research triangle park nc

Regulatory Affairs Associate (entry level)

Sr. Director, Strategic Regulatory Affairs and UDI

Regulatory Affairs Manager

Senior Manager, CMC Regulatory Affairs, Global Rare Diseases

Regulatory Affairs Manager - CMC & Labeling

QC INVESTIGATOR

Associate Director or Director, CMC Regulatory Affairs

US Regulatory Manager

Senior Associate, Regulatory CMC

Associate Director, Global Regulatory Advertising and Promotion

Regulatory Affairs Consultant, In Silico Modeling

Staff Scientist, Global Biocompatibility

Real World Evidence - Contractor

Head of US Crop Protection Regulatory Affairs - Research Triangle Park, NC (preferred)

Medical Science Liaison, Uncontrolled Gout - Rare Disease - VA, NC

Senior Nonclinical Regulatory Affairs Scientist

Associate Scientist/ Scientist/ Sr. Scientist, Pharmacometrics

Global Regulatory CMC Scientist (Raleigh)

Sr Clinical Research Associate

Director of Regulatory - Biological & Traditional Fertilizers

I want to receive the latest job alert for regulatory affairs in research triangle park nc

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