To oversee and direct regional/national submission portfolio execution associated with ~40,000 submissions worldwide to regulatory health authorities per annum, through leadership and engagement of Hub Submission Managers as part of a global business model.
Executes strategic direction, defines and upholds regional submission standards in support of new registrations and full product license lifecycle management to multiple regulatory authorities, maintaining compliance with applicable regulatory obligations while working to tight, businesscritical deadlines within a highly regulated environment.
Accountable for managing submissions when required to meet business needs and at all times maintain a comprehensive and detailed oversight of process, quality control and regulatory workload within the function.
Proactive coordination of load balancing, resources and training in support of cross regional submission activity; assessment and monitoring of trends in portfolio activity that drive changes in operating model.
To represent Submissions Management as direct partner for GRA Country Regulatory Heads for designated markets and stakeholder management across partner lines
B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); with 7+ years of relevant professional experience.
· Proven aptitude in project management and process redesign
· Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
· Demonstrated excellence in interpersonal (verbal and written) skills
· Ability to successfully establish and build collaborative relationships with colleagues within and across an organization
· Demonstrated leadership and flexibility in dealing with change and diversity as part of a global team
· Experience in resource management in a professional & dynamic environment
· Multi-lingual skills desirable.
· Familiarity with pharmaceutical organizational structures, systems, and culture is preferred
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To apply please visit our website www.pfizercareers.com and search job id 4879381 for Clinical Trials Applications Team Sr Manager.