The Everest Group


*A division of The Everest Search Group, Inc., Los
  Angeles, CA
*The Everest Search Group Inc., Lake Tahoe, NV

Ranked Top 200 of America's Best Executive Search Firms in 2017 by Forbes

Manager Regulatory Affairs Submission Management


Location: Cambridge, MA

About the Company
Our client is biopharmaceutical company with over 30,000 employees and $15 Billion in revenue focused on innovative medicines for the treatment of cancer, immunology, respiratory, diabetes, metabolic disorders, GI, neurology, CNS, inflammation, anti-virals, and vaccines among others with a strong pipeline of products in development. 

Description:

• Responsible for creating timelines for the development and submission of drug filings to regulatory health authorities 
• Retains flexibility to participate in projects as a GSM 
• The GSM is accountable for the timely delivery of compliant global submissions. 
• The position promotes a global e-working environment and drives efficient, standardized best practices for regulatory submission document management. 
• Assigned to a specific global project and partnering with the Global Regulatory Lead, this person will plan and manage regulatory submissions and author and execute submission strategy to introduce efficiencies by promoting re-use of documents, adopting global dossier principles and standardizing processes to enable simultaneous compilation and publication of submissions. 
• Ensure compliant submissions are delivered according to the worldwide regulatory submission plan and regional/country requirements. 
• Partners with document providers to facilitate the timely receipt of submission ready documents for inclusion in these global dossiers.
• Communicates external agency submission standards and internal publishing and submission processes to ensure compliance and efficiency in the delivery of submissions. 

Responsibilities:
• Responsible for ensuring appropriate GSM support on given projects. 
• Manage the cross-functional submission to deliver compliant submission components according to agreed timelines and processes. 
• Plans and manages detailed submission timelines as MS-Project schedules 
• Proactively raises any timeline concerns, risks and issues that may delay/impact the project and engages appropriate representatives to manage outcomes. 
• Understands the interdependencies among activities on a submission that could have an impact on the schedule or quality of a submission and manage to ensure that submission goals are achieved on time and to the highest quality. 
• As a global submissions expert, ensures the project team has sufficient awareness and understanding of eCTD principles and lifecycle management and understands, represents and communicates regional differences as appropriate within the context of global submission preparation
• Coordinate timely, compliant submissions, prepared for global regulatory agencies, in accordance with the worldwide regulatory submission plan.
• Maintains a 2 year submission projection for functional planning, in alignment with the Global Regulatory Strategy Plan 
• Ensures the publishing strategy maximizes document re-use and introduces efficiencies and learning from other projects and accounts for other planned registration activities. 
• Liaises with global and local cross functional areas in the creation of global submission ready documents and agrees dates for document handover  

Qualifications:
• Bachelor’s Degree in a Scientific field
• Must have experience with registrations
• 4+ years pharmaceutical industry regulatory submission experience 
• Experience creating timelines for the development and submission of drug filings to regulatory health authorities
• Comprehensive document management experience 
• Qualified project management experience
• MS Project experience
• Extensive experience working within Regulatory Operations environment and fluent understanding of submissions publishing process and requirements . 
• Fluent with the drug development process and evidence of working with Regulatory Agencies supporting regulatory dossier submission, review and approval processes
• Experience in prioritizing own and others workload.
• Proven experience in developing and implementing novel technological solutions or new processes and leading the implementation of change.
• Experience cross-functional teams within a matrix environment.
• Solid understanding of document management systems and concepts.
• Experience of multitasking in a dead-lined controlled and highly regulated environment