Senior Publisher – Regulatory Operations

📋 Description

• Oversee the preparation and submission of regulatory applications, as well as ongoing maintenance of applications, adhering to established timelines and submission dates in compliance with local and global regulatory standards for various application types (e.g., IND, NDA/BLA, MAA, CTA DMF).

• Engage in project-planning meetings to contribute insights on submission timelines in collaboration with the Manager of Regulatory Operations.

• Ensure uniformity across regulatory submission documents by adhering to the regulatory style guide (e.g., formatting, reviewing, and submitting).

• Offer technical expertise to cross-functional teams regarding the management of the lifecycle of submission-related documents.

• Conduct a final review of published submissions to guarantee consistency and compliance with regulatory standards, while ensuring accurate metadata application.

• Perform regulatory information management tasks, including file transfer, storage, tracking, and archiving of regulatory submissions.

• Uphold compliance with current Good Manufacturing Practices (cGMPs), government regulations, industry standards, approved specifications, and company policies, while remaining informed about future developments.

• Actively engage in the development of Regulatory Operations processes (SOPs/GOPs, work instructions, checklists, templates) for submission preparation and regulatory information management, while also aiding in the creation and upkeep of templates.

• Collaborate with Veeva RIM BA(s), subject matter experts, and cross-functional departments to analyze and develop processes that fulfill business needs utilizing the Veeva Vault RIM suite (Submissions and Submissions Archive).

• Foster global partnerships within the organization to assist in implementing Regulatory Operations initiatives by attending and participating in Project Teams as deemed appropriate by the manager.

• Maintain up-to-date knowledge of local and global regulatory submission requirements.

• Support Regulatory Operations' technology, including, but not limited to, publishing tools, databases, and servers.

• Ensure compliance with Company Standard Operating Procedures.

• Mentor and assist junior-level team members as needed to promote the team's growth.

• Carry out managerial responsibilities in the absence of the manager.

• Additional duties as assigned.

⛳️ Requirements

• Bachelor’s degree, preferably in a life science or a related field, or a minimum of 3-4 years of experience within a small pharmaceutical environment.

• Demonstrated experience in preparing and submitting regulatory documents, including nonclinical, clinical, CMC, DMF, and labeling/SPL, in eCTD format.

• Comprehensive knowledge and understanding of relevant FDA guidance, ICH guidelines, and other regulatory requirements.

• Proficient in using software and tools for publishing, submissions, and tracking (e.g., MS Office, Adobe Acrobat, ISI Toolbox, and at least one eCTD publishing system), as well as Veeva Vault RIM, ESG Gateway, Syncplicity (EMA Gateway), and MHRA Portal.

• Capable of assisting with the maintenance of the document management system.

• Skilled in reviewing documentation with a keen attention to detail.

• Effectively communicate and collaborate with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance in a team-oriented setting.

• Proficient in time management, adept at handling and prioritizing multiple projects/activities simultaneously while ensuring all deadlines are met.

• Proactive in identifying issues and proposing solutions as necessary.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and career growth.

• Collaborative and inclusive work environment.