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. 

The Regulatory Operations Specialist/Senior Specialist is an integral member of the Regulatory Affairs team responsible for aspects of production, compilation, and distribution of publish-ready documents for submission to regulatory authorities. The Regulatory Operations Specialist/Sr. Specialist will also publish and submit regulatory submissions and engage with cross-functional teams to support the generation of content for regulatory submissions. In addition, the position would entail regulatory document management responsibilities using Precigen’s electronic document management system (EDMS) Veeva Vault in order to maintain and provide internal access to electronic copies of submissions and/or other regulatory communications. 

DUTIES AND RESPONSIBILITES:

• 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.
• Manages document preparation, including document formatting, approval, archiving, and tracking through the Veeva Vault RIM suite.
• Maintenance, archiving, and tracking of regulatory submission documentation, including health authority correspondence, to ensure regulatory compliance and in accordance with company document standards. 
• Format, edit, review and generate publish ready PDFs of submission documents in accordance with standardized templates and 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.

EDUCATION AND EXPERIENCE:

• 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 Associates’ degree in life science, regulatory science, or related field.
• The position requires a strong knowledge-base of eCTD requirements, ICH guidelines, and Competent Authorities guidance documents as they apply to compilation of electronic submissions.

• Must be proficient in MS Office Suite. Familiarity with MS Project is preferred.
• Must have 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.

DESIRED KEY COMPETENCIES:

• Intermediate to advanced skills in Microsoft Word, Adobe Acrobat Pro DC, StartingPoint 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 www.precigen.com.