Precigen has developed novel manufacturing processes to deliver UltraCAR-T® and AdenoVerse™ immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies.

As the Senior Regulatory Affairs Associate you will be a key member of a small, dynamic, and fast-paced Regulatory team who will assist the Senior Manager, Regulatory Affairs with creating regulatory submissions in compliance with regulatory standards and guidelines and maintaining controlled documents.

Upon hire to this position Precigen will require documentation of a COVID-19 vaccination or exemption for medical or religious reasons.

DUTIES AND RESPONSIBILITIES:

• Assist with creating and maintaining regulatory timelines and tracking deliverables to timelines to ensure regulatory submission timelines are met.
• Assist with development strategy and preparation for team/project meetings.
• Assist with leading new IND submissions.
• Assist with development and/or review of regulatory documents to ensure that all submissions are of high quality.
• Assist with review of preclinical, CMC, labeling, analytical, clinical protocols and reports for regulatory compliance.
• Submit electronic data to meet deadlines and regulations.
• Interface with functional areas (Research (preclinical), Clinical, Manufacturing, QA, QC, and Regulatory Operations) to identify and obtain information required for regulatory submissions.
• Assist with preparing/coordinating/filing/managing regulatory applications, annual reports, and information amendments for multiple protocols.
• Perform literature searches and extracts information to support regulatory submission.
• Scan, file and archive documents.
• Ensure documents meet approved format and template.
• Track training requirements.
• Maintain knowledge of current global rules, regulations, and guidance documents governing pharmaceuticals.
• Collaborate in cross-functional teams.
• Assume additional responsibilities as requested.
• Support supervisor’s role.
• Demonstrate flexibility, i.e. willingly takes on new tasks.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in Life Science or Regulatory Science or related field. RAC highly preferred.
• Five (5) years of regulatory experience in a biotech/pharma setting preferred.
• Excellent knowledge of Adobe and MS Office (Word, Excel, PowerPoint.)
• Knowledge of Veeva Vault, and Regulatory Templates preferred.
• Ability to learn new software quickly.

DESIRED KEY COMPETENCIES:

• Strong organization and time management skills, an ability to work on multiple projects simultaneously, and excellent attention to detail.
• Ability to understand and execute on the company’s mission and values.
• Self-organizer, keen attention to detail.
• Highly motivated with excellent interpersonal, collaborative and team-oriented skills to work well with the rest of the organization and build relationships with suppliers.
• Perform other responsibilities to support the needs of the department, as assigned.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Demonstrated ability to work and coordinate with multiple stakeholders.
• Exhibition of the highest degree of ethical standards and trustworthiness.

EOE MFDV