Plasma Regulatory Affairs Associate

job summary:
Advance your career in Durham, NC with a global leader in plasma therapies! This position features a balanced hybrid schedule (on-site Monday through Wednesday) and offers a dynamic opportunity to support licensing, compliance, and regulatory activities for life-saving source plasma collection across the US and international markets.

location: Durham, North Carolina
job type: Contract
salary: $28 - 35 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Accurately prepare, format, and assemble regulatory applications required by federal authorities (including the FDA and Health Canada).
• Submit applications, monitor review timelines, and correspond routinely with regulatory authorities to resolve inquiries.
• Maintain contemporaneous regulatory files, shared mailboxes, and administrative licensing dashboards for full transparency.
• Educate internal stakeholders and plasmapheresis centers regarding licensing and compliance requirements.
• Process and track regulatory invoices while assisting with the evaluation of regulatory changes impacting the business.

 
qualifications:

Required:

• Bachelor's degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology).
• High proficiency using Microsoft Office (Word and Excel) and Adobe PDF to edit and format documentation.

Preferred:

• 1+ years of regulatory experience in the plasma collection, blood, or pharmaceutical industry.

#LI-AB1

skills: Good Laboratory Practices (GLP), Regulatory Submission Compliance, FDA Submissions


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on randstadusa.com.


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.