SUMMARY: We are seeking a motivated individual to join our Regulatory Operations group and provide document publishing and submission support to our key stakeholders. Primary responsibilities will include Word document processing/formatting, PDF publishing/QC review, compilation of eCTD submissions for various Health Authorities, and archiving consistent with global regulatory requirements for different application types. This position will report to and work closely with the Regulatory Operations Director and eCTD vendors to enable various types of electronic submissions.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Create and format various basic to complex Word documents, utilizing internal processes and tools to perform the activities pertaining to electronic publishing and to meet required standards and technical requirements within specified timelines.
- Maintain StartingPoint templates for submission documents and support others on their use.
- Electronically publish components of Regulatory Agency submissions in compliance with global regulatory requirements for different application types (i.e., INDs, BLA/NDA, MAA CTA, etc.).
- Format, edit, proof, and create bookmarks and hyperlinks according to guidance and internal processes.
- Ensure consistency across regulatory submission documents following the regulatory style guide.
- Work with relevant internal staff to ensure that source documents are received in a timely manner in order to support the generation of submissions.
- Provide technical expertise to cross-functional teams on format, style, and structure of compliant documents for electronic submissions.
- Provide input and guidance for scheduling and planning submissions.
- Conduct QC of published submissions to ensure consistency and compliance with regulatory requirements.
- Execute regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submission documents/correspondence.
- Participate in the development of Regulatory Operations processes (SOPs, work instructions, guidelines, templates) for preparing submissions and regulatory information management.
- Assist in the review of Regulatory Operations work practices.
- Bachelor’s degree or equivalent experience and 5 - 7 years’ experience in Regulatory Operations, including experience with electronic submissions.
- In‑depth, hands-on experience and expert‑level skills in Word processing, formatting, and PDF publishing for electronic submissions.
- Relevant experience with electronic document management and publishing systems (eg, Veeva, Box), eCTD Validation tools (Lorenz eValidator, Rosetta Phoenix) and other publishing and QC tools (PDF Tools, PDF Toolbox), global regulatory submissions, or other experience directly related to Regulatory Operations.
- Demonstrated ability to work effectively in a fast-paced environment with multiple high-priority projects.
- Knowledge of IT systems and electronic submission requirements and processes
- Proficiency with MS Word and Adobe is a MUST.
- Strong interpersonal skills, including the ability to remain calm, professional, diplomatic, and positive.
- Detail oriented with a high degree of organizational skills and be able to handle confidential materials.
- Ability to work independently and efficiently, and to set priorities and meet timelines.