The Manager Regulatory Affairs Global Development supports development and lifecycle regulatory activities across assigned products and clinical programs. This role serves as the Regulatory Affairs lead for assigned projects owning regulatory deliverables and acting as a key point of contact for cross-functional teams.

The individual operates with a high degree of autonomy for assigned responsibilities applying regulatory knowledge and critical thinking to interpret data ensure compliance and guide regulatory activities with minimal direction. This role contributes to regulatory strategy execution and proactively identifies risks drives solutions and escalates as needed to support successful regulatory outcomes.

• Serve as the Regulatory Affairs lead for assigned clinical programs and submissions acting as the primary point of contact for regulatory activities
• Lead preparation organization and QC review of regulatory submissions (e.g. INDs NDAs amendments supplements)
• Manage submissions end-to-end from planning through publishing and final delivery in partnership with Regulatory Operations
• Own and drive regulatory deliverables ensuring alignment with timelines quality standards and regulatory requirements
• Contribute to the development and execution of regulatory strategies for assigned programs applying regulatory knowledge and critical thinking
• Interpret regulatory requirements and assess their impact on study design submissions and documentation
• Identify regulatory risks support development of mitigation strategies and drive issue resolution or escalation as needed
• Lead and/or facilitate cross-functional alignment and provide regulatory guidance to ensure consistency accuracy and compliance across deliverables
• Represent Regulatory Affairs on cross-functional teams clearly communicating regulatory considerations timelines and risks to stakeholders

Minimum Job Requirements

Education & Experience

• Bachelors degree in a scientific discipline such as life sciences pharmacy bioscience; advanced degree preferred.
• 5 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
• Experience supporting US regulatory drug development activities based on FDA and ICH requirements.
• Demonstrated experience supporting or leading components of regulatory submissions (e.g. INDs NDAs) and lifecycle management activities in alignment with FDA and ICH requirements
• Experience preparing and maintaining regulatory submissions and source documentation; familiarity with publishing/QC processes.

Competencies

• Ability to independently manage regulatory deliverables from planning through submission ensuring timely high-quality outcomes with minimal oversight
• Comfortable operating in a fast-paced environment with evolving priorities applying regulatory knowledge to adapt and respond effectively
• Drives alignment and progress across teams without direct authority effectively partnering with stakeholders to achieve regulatory objectives
• Maintains high standards for accuracy completeness and compliance across all regulatory deliverables
• Identifies risks early applies sound judgment and takes appropriate action or escalation to resolve issues
• Clearly communicates regulatory considerations risks and timelines to cross-functional stakeholders including presenting to study and project teams as needed
• Ability to manage multiple priorities with strong attention to detail while meeting established timelines

Other Requirements

• This role has decision-making authority within assigned regulatory activities and deliverables with escalation of complex high-risk or strategic decisions.
• Ability to travel up to 10% (domestic and international).
• 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 base salary range for this full-time position is $120000-$150000. 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.

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