Senior Regulatory Operations Associate Contractor - Shionogi Inc.

The Senior Regulatory Operations Associate Contractor will lead in the preparation and submission of electronic regulatory documents through the FDA, EMA, MHRA, and HealthCanada 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 formatting and publishing regulatory documents, managing document tracking and version control, archiving on- and off-site, 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 submission documents/correspondences.
• 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 document formatting, 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.

ESSENTIAL PHYSICAL REQUIREMENTS 

• Ability to articulate clearly and conduct verbal presentations with large and small audiences.
• Ability to travel via automobile and/or airplane.
• Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time.
• Ability to operate a computer keyboard and telephone.
• Ability to sit for extended periods of time – up to four (4) hours at a time.
• Ability to lift, tug, pull up to fifteen (15) pounds.

DISCLAIMER

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice. 

Shionogi Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, 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 in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.