Regulatory Affairs Specialist

Job Title: Plasma Regulatory Affairs Associate

Location: Durham, NC 27701

Duration: 12 Months contract (Potential temp to Perm)

Payrate: $28/hr. - $35/hr. (depending on experience)

Shift: 1st shift, Mon-Fri, 8am-4:30pm

Start Date: ASAP

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.

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.

Knowledge skills and abilities:

• Ability to work with limited supervision and initiate contacts essential to submission preparation.
• Understanding of the regulatory requirements for licensing applications and reporting.
• Ability to follow standardized processes in a regulated environment.
• Ability to review documents in detail to ensure accuracy based on regulatory requirements, and to ensure the use of the appropriate forms, format, content, and authorized signatures.
• Strong organizational skills with the ability to manage multiple tasks and prioritize effectively in a deadline driven environment.
• Ability to effectively use Microsoft Office (particularly Word and Excel) and Adobe PDF to create, edit, and format documents.
• Ability to complete assigned tasks within the required timelines.
• Ability to successfully interact with regulatory bodies and cross-functional teams through professional, articulate, and courteous conversations and clear, concise written communications.
• Ability to elevate potential concerns/discrepancies to supervisors or management in a timely fashion.
• Works collaboratively as part of the regulatory team to meet group objectives.
• Models and demonstrates high standards of integrity, trust, openness, and respect for others.
• Take initiative; look for opportunities to act and contribute to the team's success.
• Ability to demonstrate openness to constructive feedback in order to improve on a continuous basis.
• Makes good use of unsupervised time.
• Ability to connect individual responsibilities with company mission and department goals to meet business objectives while being a good representative of the company."

Education:

Bachelor's Degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology).

Experience:

• Preferred two (2) years related technical and/or regulatory experience in pharmaceutical or blood industry.
• Experience with Microsoft Office.
• Experience with Adobe PDF.
• Experience in plasma collection, pharmaceutical industry, or a regulated field.