Regulatory Affairs Associate

Job Title: Regulatory Affairs Specialist - Plasma Licensing

Job Description

This role supports plasma regulatory affairs by preparing, submitting, and maintaining licensing, registration, and accreditation documentation for source plasma collection activities in the United States, Canada, and other global regions. You will help ensure compliance with regulatory authorities and industry associations by managing applications, monitoring submissions, and communicating requirements to internal stakeholders. This position offers the opportunity to contribute to life‑changing therapies within a mission‑driven organization focused on improving patient lives.

Responsibilities

• Accurately prepare regulatory applications required by federal and other regulatory authorities, as well as industry affiliates, for review prior to submission.
• Research internal documents, complete applications and forms, prepare cover letters and summaries, and assemble and format applications to facilitate efficient regulatory review.
• Submit regulatory applications and monitor their progress to ensure timely review and acceptance by regulatory agencies.
• Respond promptly and professionally to inquiries from regulatory authorities and provide any additional documentation or clarification required.
• Provide regular updates to management on the status of regulatory applications and related activities.
• Escalate urgent and time‑sensitive matters that may impact regulatory compliance to management in a timely manner.
• Maintain regulatory files contemporaneously to ensure transparency, traceability, and adherence to timelines.
• Maintain shared mailboxes, dashboards, and accounts related to administrative licensing activities, ensuring they are current and well organized.
• Archive and distribute regulatory applications electronically and in hard copy, following established processes and retention requirements.
• Record the details of pertinent conversations and written interactions with regulatory authorities, as appropriate, to maintain complete and accurate records.
• Educate and inform internal stakeholders at corporate offices and plasmapheresis centers about regulatory requirements related to licensing activities.
• Provide registration and licensing documentation to internal and external stakeholders in a timely and accurate manner.
• Assist in evaluating regulatory changes and assessing their impact on business operations and licensing requirements.
• Process and track all invoices associated with licensing activities to ensure prompt and accurate payment.
• Follow standardized processes and procedures in a regulated environment to support consistent and compliant regulatory operations.
• Collaborate with cross‑functional teams and members of the regulatory affairs group to meet shared objectives and project timelines.
• Identify and raise potential concerns or discrepancies in regulatory documentation or processes to supervisors or management.
• Use unsupervised time effectively by proactively advancing assigned tasks and contributing to team goals.
• Act as a professional representative of the organization in all interactions with regulatory bodies and internal partners.

Essential Skills

• Ability to work with limited supervision and independently initiate the contacts and activities necessary to prepare regulatory submissions.
• Strong understanding of regulatory requirements for licensing applications and reporting within pharmaceutical, blood, or plasma‑related industries.
• Proven ability to follow standardized processes in a regulated environment and adhere to documented procedures and instructions.
• High attention to detail with the ability to review documents thoroughly for accuracy, completeness, and alignment with regulatory requirements.
• Ability to ensure the correct forms, formats, content, and authorized signatures are used in all regulatory submissions.
• Strong organizational skills with the ability to manage multiple tasks, prioritize effectively, and meet deadlines in a time‑sensitive environment.
• Proficiency in Microsoft Office, particularly Word and Excel, to create, edit, and format documents and tracking tools.
• Proficiency with Adobe PDF tools to create, edit, and format regulatory documents and submissions.
• Ability to complete assigned tasks within required timelines while maintaining high quality and compliance standards.
• Strong written and verbal communication skills, with the ability to interact professionally, clearly, and courteously with regulatory bodies and cross‑functional teams.
• Ability to recognize and escalate potential concerns or discrepancies to supervisors or management in a timely fashion.
• Demonstrated ability to work collaboratively as part of a regulatory team to meet group objectives.
• Commitment to high standards of integrity, trust, openness, and respect in all professional interactions.
• Initiative and a proactive approach, with a focus on identifying opportunities to contribute to team and organizational success.
• Openness to constructive feedback and a continuous improvement mindset.
• Ability to connect individual responsibilities with the broader company mission and departmental goals to support business objectives.
• Bachelor's degree in a scientific discipline such as Pharmacy, Chemistry, Biology, or a related field.
• Preferred minimum of two (2) years of related technical and/or regulatory experience in the pharmaceutical or blood industry.
• Experience working in plasma collection, the pharmaceutical industry, or another regulated field.

Additional Skills & Qualifications

• Experience preparing and managing regulatory submissions for agencies such as the US Food and Drug Administration (FDA), including biologics license applications (BLA) and medical device registrations.
• Familiarity with Health Canada licensing requirements and processes.
• Exposure to Clinical Laboratory Improvement Amendments (CLIA) activities and related compliance requirements.
• Experience supporting Plasma Protein Therapeutics Association (PPTA) membership and certification activities.
• Familiarity with COLA accreditation processes and state or provincial licensing requirements.
• Experience with licensing or regulatory activities for regions outside the United States and Canada (Rest of World).
• Background in regulatory quality or quality‑focused roles, with an emphasis on documentation accuracy and compliance.
• Demonstrated ability to interpret written and verbal instructions accurately and apply them consistently.
• Comfort routinely corresponding with regulatory authorities and external stakeholders in a professional manner.
• Strong invoice processing and tracking skills related to regulatory and licensing activities.
• Interest in contributing to life‑changing therapies and working within a mission‑driven, patient‑focused organization.
• Desire to work in a collaborative culture that emphasizes training, professional development, and access to cutting‑edge science.

Work Environment

This is an onsite position with a standard Monday through Friday schedule, typically from 8:00 a.m. to 4:30 p.m. You will work in a professional office environment that supports plasma regulatory affairs activities, using tools such as Microsoft Office (Word, Excel) and Adobe PDF for document creation, editing, and formatting. The role involves frequent interaction with corporate colleagues and staff at plasmapheresis centers, as well as routine correspondence with regulatory authorities. The culture emphasizes collaboration, integrity, and continuous learning, offering strong training resources, exposure to advanced scientific and regulatory practices, and a supportive environment where your work directly contributes to improving patient lives.

Job Type & Location

This is a Contract position based out of Clayton, NC.

Pay and Benefits

The pay range for this position is $28.00 - $35.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Clayton,NC.

Application Deadline

This position is anticipated to close on Jun 12, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.