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 noneCTD 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 crossfunctional teams and identifying opportunities for process improvement.

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 noneCTD 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 crossfunctional teams and identifying opportunities for process improvement.

Responsibilities

• 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 crossfunctional teams on structure of compliant documents for electronic submissions.
• Coordinate with crossfunctional 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 12 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

• Proficient 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 crossfunctional teams regardless of level
• Adept at handling and prioritizing multiple projects/activities simultaneously while ensuring all deadlines are met.
• Ability to work collaboratively with crossfunctional 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

• No 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.

To be considered for this position you must apply and meet the requirements of this opportunity.

We look forward to reviewing your resume & qualifications.

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 nondiscriminatory.

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