Global Submission Manager

Role Summary

The Global Submission Manager applies global expertise in managing all submission types for the GRA portfolio, from standard to complex. They represent GRO on Global Regulatory Teams for assigned products and provide key input with insight into development plans. The Global Submission Manager oversees operational submission planning and decision making, prioritizes workload, and negotiates timelines with key stakeholders. They collaborate with Publishers/Submission Associates to prepare submissions according to plan and, for Global Simultaneous Submissions, work in an agile model with the Submission Lead and global colleagues to deliver regional expertise and global filing plans.

Location:

Morristown, NJ.

• Applies project management skills and regulatory knowledge for global submission types, from standard to complex.
• Applies expert understanding on all dossier formats, standards, navigation and lifecycle management, eCTD, and ICH.
• Represents GRO Global Submissions Management on Global Regulatory Teams (GRTs) for assigned development and marketed products portfolio, per the GRA Blue Print model.
• Represents GRO Global Submissions Management on Submission Task Force (STF) meetings for major/complex submission filings and partners effectively with regulatory focal points on the Ops-specific details of lifecycle submissions.
• Leads discussions with stakeholders and submission task force teams involving electronic guidance issues to ensure understanding of electronic submission requirements, supporting successful submissions. Works within project teams to control submission component receipt and adherence to completion.
• Directs publishing activities for the assigned portfolio to ensure high quality and timely submission delivery aligned to standards.
• Partners effectively with Submission Leads and global colleagues to deliver high quality and timely Global Simultaneous Submissions (GSS) filing plans, while providing regional expertise.
• Acts as Subject Matter Expert (SME) in audits/inspections, special projects and issue resolution for regional activities.
• Partners with GRA and Digital functions as SME for current processes/data/technologies, evaluating and implementing new/emerging technologies and requirements.
• May be assigned supervisory responsibilities.

• Bachelor’s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study.
• Minimum 5+ years of experience in the pharmaceutical industry, with direct regulatory affairs experience.
• High degree of knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers.
• Working knowledge of drug laws, regulations and guidelines.
• Ability to work across cultures.

• Expert knowledge of global submission standards and specifications.
• Strong understanding of global regulatory requirements, submission processes and the drug development process.
• Experience in planning, coordinating and managing different stages of submission development.
• Expertise in the eCTD process, document management environments/systems, publishing tools and submission software.
• Ability to learn quickly and adapt to new technologies/environments.
• Self-starter with agile and positive approach; strong leadership, negotiating and influencing skills.
• Ability to lead complex projects and timelines in a matrix team environment.
• Ability to identify issues, analyze complex problems and propose creative, feasible solutions.
• Strong attention to detail and accuracy; excellent verbal and written communication skills.
• Ability to cultivate internal and external relationships.
• Proficiency with eCTD publishing tools, RIM systems, MS Windows, MS Office, and Adobe Acrobat.

• Bachelor’s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study.

• Strong command of the English language, both spoken and written.
• Ability to operate with agility in a dynamic global environment.
• Ability to maintain discretion and confidentiality about sensitive data.
• Ability to communicate and collaborate at many levels, including escalation to leadership.