Regulatory Operations Specialist

Precigen is seeking a highly motivated Regulatory Operations Specialist/Senior Specialist (level determined by candidate experience) to work within our Regulatory Affairs team in Germantown, Maryland.

As an integral member of the Regulatory Affairs team, the Regulatory Operations Specialist/Senior Specialist is responsible for the production, compilation, and distribution of publish‑ready documents for submission to regulatory authorities, publishing and submitting regulatory submissions, and engaging with cross‑functional teams to support the generation of content for regulatory submissions.

Role responsibilities include:

• Responsible for the completeness and quality of regulatory submissions from the operations perspective. Interacts with internal and external teams to support timely submission of information to regulatory authorities.
• Publish and submit regulatory submissions to competent authorities.
• Manage document preparation, including formatting, approval, archiving, and tracking through the Veeva Vault RIM suite.
• Maintain, archive, and track regulatory submission documentation, including health authority correspondence, to ensure regulatory compliance in accordance with company document standards.
• Format, edit, review, and generate publish‑ready PDFs of submission documents in accordance with standardized templates and the Regulatory Style Guide.
• Perform document quality control checks for others in the department to identify potential risks or issues and suggest and implement solutions under guidance.
• Participate in Regulatory Operations process improvement and system initiatives.
• Provide support for Regulatory Systems Releases via Precigen’s change control process.

• Two (2)+ years in pharma/biopharma/contract research organization (CRO) regulatory, with a minimum of one (1) year Regulatory operations/publishing/submissions/eCTD experience.
• Minimum Associate’s degree in life science, regulatory science, or related field.
• Strong knowledge of eCTD requirements, ICH guidelines, and Competent Authorities guidance documents as they apply to compilation of electronic submissions.
• Proficient in MS Office Suite; familiarity with MS Project is preferred.
• Experience publishing eCTD submissions; experience with Veeva Vault RIM and Lorenz dB publishing application is highly desirable.
• Experience with drugs/biologics therapy is preferred.
• Knowledge and experience in the management of electronic regulatory documents using an electronic document management system (EDMS) is required.
• Experience and knowledge of User Acceptance Testing is preferred.

• Intermediate to advanced skills in Microsoft Word, Adobe Acrobat Pro DC, Starting Point Templates, eCTD publishing, and EDMS such as Veeva Vault.
• 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.
• Clear communication in both oral and written form.
• Demonstrated ability to work and coordinate with multiple stakeholders.
• Exhibition of the highest degree of ethical standards and trustworthiness.

EOE MFDV

Precigen (Nasdaq: PGEN) is a dedicated commercial, 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. We invite you to discover more at