Senior Regulatory Operations Publisher - Contractor

This role will lead in the preparation and submission of electronic regulatory documents through the FDA, EMA, MHRA, and Health Canada Electronic Submission Gateways (ESG,), as well as prepare and file non-eCTD submissions, to ensure compliance with applicable laws and regulations.  The scope of this role includes publishing regulatory documents, managing document tracking and version control, maintaining a thorough understanding of regulatory requirements, collaborating with cross-functional teams, and identifying opportunities for process improvements.  In addition to these standard publishing requirements, the Senior Regulatory Operations Associate will bring project management skills and technical experience in document management and publishing systems to this role.

Below is a list of the main activities needed to fulfill the requirements of the role. It is not meant to be a comprehensive list, but rather, provide an overview of the specialized skills and expertise required:

• Lead in the preparation and submittal of regulatory applications and on‐going application maintenance in accordance with established timelines and submission dates in compliance with local and global regulatory requirements for the different application types (eg, IND, NDA/BLA, MAA, CTA DMF). Participate in project-planning meetings to provide input on submission timelines in collaboration with Manager, Regulatory Operations.
• Ensure consistency across regulatory submission documents following the regulatory style guide (i.e. formatting, reviewing, and submissions).
• Provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents.
• Conduct final review of published submissions to ensure consistency and compliance with regulatory requirements, as well as ensure metadata is correctly applied.
• Execute regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submissions.
• Maintain compliance with current Good Manufacturing Practices (cGMPs), government regulations, industry standards, approved specifications, and Company procedures and directives while continuing to stay well-informed on future developments.
• Actively participate in the development of Regulatory Operations processes (SOPs/GOPs, work instructions, checklist, templates) for preparing submissions and regulatory information management, in addition to assisting in the creation and maintenance of templates.
• Work with Veeva RIM BA(s), subject matter experts, and cross functional departments to analyze and develop processes that support business needs using the Veeva Vault RIM suite (Submissions and Submissions Archive)
• Develop global partnerships across the organization to help implement Regulatory Operations’ initiatives by attending and participating in Project Teams if deemed appropriate by manager.
• Maintain knowledge of local and global regulatory submission requirements.
• Assist in supporting Regulatory Operations’ technology including, but not limited to publishing tools, databases, and servers.
• Ensure adherence to Company Standard Operating Procedures.
• Mentor and support junior-level team members as needed to help facilitate the team’s growth.
• Perform managerial activities in manager’s absence.
• Other duties as assigned.

Minimum Job Requirements

• Bachelors’ degree, preferably in a life science or a related field or a minimum of 3-4 years of experience in a small pharmaceutical environment.
• Proven experience in preparing and submitting regulatory documents, including nonclinical, clinical, CMC, DMF, and labeling/SPL., in eCTD format.
• Thorough knowledge and understanding of relevant FDA guidances, ICH guidelines and other regulatory requirements.
• Proficiency in using:
  • Software and tools for publishing, submissions, and tracking (i.e. MS Office, Acrobat Adobe, ISI Toolbox, and at least one eCTD publishing system)
  • Veeva Vault RIM, ESG Gateway, Syncplicity (EMA Gateway), and MHRA Portal
  • Able to assist with maintenance of document management system
• Capable of reviewing documentation with a high degree of attention to detail.
• Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance in a team‐oriented environment.
• Adept at effective time management in handling and prioritizing multiple projects/activities simultaneously while ensuring all deadlines are met.
• Proactive to identify issues and propose solutions as necessary.

Additional Information

The hourly rate for this position is $48-70. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role. 

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.

If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.