Regulatory Operations – Level 2 - Publisher (Contractor)

Shionogi Inc.•Florham Park, NJ

1d•Hybrid

About The Position

This role will support in the preparation and submission of electronic regulatory documents through the FDA and Health Canada Electronic Submission Gateways (ESG), as well as, prepare and file non-eCTD submissions to ensure compliance with applicable laws and regulations. This 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 improvement.

Requirements

Minimum of 1-2 years of experience required within a pharmaceutical regulatory environment, including eCTD publishing of INDs and NDAs.
Acquired knowledge of nonclinical, clinical, CMC, DMF, and labeling/SPL submission documents.
Familiar with regulatory guidelines, such as FDA, EMA, MHRA, and Health Canada.
Knowledge and understanding of relevant Health Authority guidance and other regulatory requirements
Proficiency in using: MS Office, Acrobat Adobe, ISI Toolbox, and at least one eCTD publishing system
Proficiency in using: Veeva Vault RIM
Proficiency in using: ESG Gateway
Capable of reviewing documentation with a high degree of attention to detail.
Effective communicator adept at communicating with cross-functional teams, regardless of level
Adept at handling and prioritizing multiple projects/activities simultaneously while ensuring all deadlines are met.
Ability to work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance in a team‐oriented environment.
Capable of managing time effectively, prioritize tasks in order to meet objectives in a timely manner.
Adept at identifying issues and propose solutions as necessary.
Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.
Office presence required at least 50% of the time per month

Nice To Haves

Prior knowledge of CTAs/MAAs a plus.
Bachelor’s degree preferred

Responsibilities

Support 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).
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 structure of compliant documents for electronic submissions.
Coordinate with cross-functional teams, including Regulatory Affairs, Clinical Development, and Quality Assurance, to obtain the necessary information to ensure timely submission of regulatory documents.
Conduct review of published submissions to ensure consistency and compliance with regulatory requirements.
Perform quality control checks on documents to ensure accuracy and completeness, as well as resolve any issues that arise.
Execute regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submissions.
Maintain knowledge of local regulatory submission requirements.
Ensure adherence to Company Standard Operating Procedures.
Maintain compliance with current Good Manufacturing Practices (cGMPs), government regulations, industry standards, approved specifications, and Company procedures and directives.
Supports in the review of Regulatory Operations processes (SOPs, work instructions, checklists, templates) for preparing submissions and regulatory information management.
Other duties as assigned.