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.

• Support in the preparation and submittal of regulatory applications and ongoing 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.

Minimum Job Requirements

Qualifications

• Minimum of 1-2 years of experience required within a pharmaceutical regulatory environment including eCTD publishing of INDs and NDAs. Prior knowledge of CTAs/MAAs a plus.
• Bachelors degree preferred
• 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

Competencies

• Proficiency in using:
  • MS Office Acrobat Adobe ISI Toolbox and at least one eCTD publishing system
  • Veeva Vault RIM
  • 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 teamoriented 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.

Other Requirements

• Not travel is required in this position
• 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

Additional Information

The hourly rate for this position is $40 - $57. 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 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.

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