Position Title: Regulatory Affairs Specialist

Location: Austin, TX

Compensation: 75K - 80K base

Full Time – Direct Hire

Purpose:

The Regulatory Affairs Specialist is responsible for ensuring Company compliance with regulatory requirements and standards related to the collection and processing of source plasma, as well as assisting with the analysis and communication of unexpected events associated with plasma collection and distribution.

Principal Duties & Responsibilities:

• Support established systematic methods to effectively survey the safety, purity, and potency of products collected and distributed.
• Assist with identification and investigation of events that require a Biologic Reportable Deviation (BPD) as per 21 CFR 606.171, to include a deviation from current Good Manufacturing Practice, applicable regulations, applicable standards, or established specifications that may affect the safety, purity, or potency of that product; or an unexpected or unforeseeable event that may affect the safety, purity, or potency of that product; and involves distributed blood or blood components.
• Assist with review of non-conforming products.
• Participate in customer notifications regarding product suitability for use, distribution, or recall.
• Prepare reports of adverse events for FDA review before expected deadlines.
• Support external inspections by regulatory agencies, as assigned, and facilitate optimal communication between the department and the inspectors/assessors.
• Support organizational projects from a regulatory and/or quality perspective and complete assigned tasks in a timely manner.
• Maintain comprehensive knowledge of current regulations and standards and provide guidance to internal stakeholders on compliance issues.
• Maintain up-to-date knowledge of quality issues through participation in meetings, task forces, and self-directed learning.
• Support in the maintenance of accurate regulatory documentation, including submissions, licenses, and approvals. Ensure that all required records are up-to-date and available for audits.
• Assist with the preparation of regulatory submissions for new facilities, products, variances, or renewals. Collaborate with cross-functional teams to gather necessary information and ensure timely submission to regulatory authorities.
• Support the maintenance of metrics to track regulatory compliance performance.
• Contribute to the organizational mission via professionalism in customer service interactions and accuracy of work.
• Promote teamwork and communication.
• Foster a team environment to facilitate effective management.
• Other duties as assigned.

Knowledge, Skills, and Abilities:

• Strong skills in communication with team members, and internal and external departments.
• Problem-solving and strategic planning abilities; experience in performing root cause analysis.
• Strong research, writing, and verbal communication skills.
• Strong computer skills, including familiarity with compliance programs, document management software, and project management software.
• Understanding of Code of Federal Regulations (CFR) Title 21 compliance; AABB Standards and CLIA requirements.
• Ability to travel up to 10% of the time.

Education and Experience:

• Bachelor’s degree preferred.
• At least two (2) years’ experience in biologics, biotechnology, or the pharmaceutical industry with increasing regulatory responsibilities or equivalent combination of education and experience.
• Regulatory experience preferred.

Job Type: Full-time

Pay: $75,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• Can you commute to the office on daily basis?
• Do you have FDA regulatory affairs experience?
• Are you familiar with CFR Title 21, AABB Standards, and CLIA?

Ability to Relocate:

• Austin, TX 78704: Relocate before starting work (Required)

Work Location: In person