Regulatory Affairs Manager

Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.

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 Director, Regulatory Affairs with creating regulatory submissions in compliance with regulatory standards and guidelines and maintaining controlled documents.

This will be an onsite role in our Germantown, Maryland facility.

DUTIES AND RESPONSIBILITIES:

• Lead the preparation, authoring, review, and submission of CMC sections (Module 3 and relevant Module 2 summaries) for INDs, IMPDs, NDAs/BLAs, MAAs, and post‑approval supplements.
• Evaluate the regulatory impact of proposed manufacturing, analytical, or quality changes.
• Support global product maintenance activities, including annual reports, and responses to health authority questions.
• Assume additional responsibilities as requested.
• 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.
• Minimum of 5 years of experience in the biotech/pharmaceutical industry, and a minimum of 3 years in regulatory affairs in a clinical-stage and/or commercial biotechnology company 
• Experience leading and developing commercial Biologics marketing applications preferred 
• Solid understanding of global regulatory guidance and ICH guidelines 
• Strong experience with CTD format and content of regulatory filings 
• 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.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Ability to understand and execute on the company’s mission and values.
• Demonstrated ability to work and coordinate with multiple stakeholders.
• Exhibition of the highest degree of ethical standards and trustworthiness 
• Perform other responsibilities to support the needs of the department, as assigned.

EOE MFDV