Regulatory Affairs Manager

Precigen, Inc • Germantown, MD

15h • Onsite

About The Position

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 immuno-oncology, autoimmune disorders, and infectious diseases. The company has developed novel manufacturing processes for UltraCAR-T® and AdenoVerse™ immunotherapies and has multiple products in clinical evaluation. The Senior Regulatory Affairs Associate will be a key member of a small, dynamic, and fast-paced Regulatory team, assisting the Director, Regulatory Affairs with creating regulatory submissions in compliance with regulatory standards and guidelines and maintaining controlled documents. This is an onsite role located in Germantown, Maryland.

Requirements

• Bachelor’s degree in Life Science or Regulatory Science or related field.
• Minimum of 5 years of experience in the biotech/pharmaceutical industry.
• Minimum of 3 years in regulatory affairs in a clinical-stage and/or commercial biotechnology company.
• 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).
• Ability to learn new software quickly.

Nice To Haves

• RAC highly preferred.
• Experience leading and developing commercial Biologics marketing applications preferred.
• Knowledge of Veeva Vault, and Regulatory Templates preferred.
• Strong organization and time management skills.
• Ability to work on multiple projects simultaneously.
• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 11-50 employees