Regulatory Operations Publisher (Contract)

About the position

Precigen is seeking a highly motivated and skilled Regulatory Operations Publisher (contract) to work with our Regulatory Affairs team in Germantown, Maryland. The Regulatory Operations Publisher will be responsible for aspects of production, compilation, and coordinating with the contracted publisher for the submission of regulatory documents required for filing INDs, DMFs, NDAs or BLAs, including original submissions, subsequent amendments and periodic reports to regulatory authorities. We anticipate a six month contract with the potential to convert to full time.

Responsibilities

• Maintenance and tracking of regulatory submission documentation, including regulatory authority correspondence, in an appropriate electronic document management system (Veeva Vault RIM) or hardcopy archive location 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.
• Assure completeness and quality of submissions from the operations perspective, identifying issues, suggests and implements solutions under guidance.
• Perform document quality control checks for others in the department, promptly communicating irregularities in documents and coordinating issue resolution.
• Coordinate submission planning and timelines with external vendor to publish submissions and execute electronic submission through the FDA's Electronic Submissions Gateway.
• Maintenance of submission archive using Precigen's EDMS Veeva Vault RIM Suite.
• Participate in Regulatory Operations process improvement and system initiatives.
• Provide support for Veeva Vault Rim Releases via Precigen's change control process.

Requirements

• Bachelor's degree or equivalent combination of education and experience.
• Three (3)+ years of regulatory experience in pharma/biopharma/contract research organization (CRO) regulatory, with a concentration in submissions/eCTD publishing.
• Strong knowledge-base of eCTD requirements, ICH guidelines, and FDA guidance documents as they apply to compilation of electronic submissions.
• Knowledge and experience in the management of electronic regulatory documents using an electronic document management system (EDMS). Experience and knowledge of User Acceptance Testing is preferred.
• Proficient in MS Office Suite.

Nice-to-haves

• Intermediate to advanced skills in Microsoft Word, Adobe Acrobat Professional, and regulatory electronic document management system (Veeva Vault RIM), publishing applications including Lonza Docubridge.
• 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.
• Exceptional organization skills with strong attention to detail.
• Strong personal leadership and self-direction.
• Clear communication in both oral and written form.
• Demonstrated ability to work with and coordinate demands from multiple stakeholders.
• Exhibition of the highest degree of ethical standards and trustworthiness.