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A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Provides an interface to Regulatory partners within designated Business Units, delivering regulatory operational leadership and expertise in the logistics and internal/ external requirements/regulations involved with execution and submittal of regulatory submissions to regional partners and selected Health Authorities. Contributes to budget/cost center management.
• The Global Submission Manager (GSM) Director has overall accountability to lead regulatory operational execution of submissions through to approvals for designated major portfolio assets (all Business Units). They function as regulatory operational Subject Matter Expert for major assets and drive submission teams towards timely and quality delivery of globally compliant submission-ready components which enable successful build and submittal of dossiers.
• The GSM will guide and advise the Global Asset Team on FDA and EMA guidance and policies as related to ICH electronic submission regulations including but not limited to dossier format and navigation. Additionally, they provide awareness of important factors to consider, such as re-use and potential modification of documentation and data for multiple markets when developing Marketing Applications.
• The GSM partners with Asset Team Members including and when appropriate, on behalf of Global Regulatory strategy and is a core team member of the asset level cross functional submission team.
This role is introduced around the time of the Phase 2/3 decision to pursue a Marketing Application through to approval in primary markets and thereafter expansion in Emerging Markets. As such, this role is typically activated and part of an asset team 18 months prior to first dossier submittal, taking a dominant logistical role through 'end game' and thereafter for continued expansion into designated markets.
• The GSM serves as the WRO primary point of contact for Global Asset Teams working on Major Applications (e.g. WRS Strategist, Functional Line SMEs and Content Authors) and will provide direction to Publishing Managers as dossiers are prepared and managed appropriately throughout the company processes and systems. The GSM routinely interfaces with Hub Submission Managers and periodically with Country Office colleagues to support timely and quality submissions in relevant markets.
• The GSM must successfully understand and articulate implications of filing strategy with regards to new Marketing Applications and Major Line Extensions through to approval, including assessment and practical management of associated impacts across dossiers.
• The GSM is accountable as a key member of development teams and relevant endgame committees, to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities.
• The GSM engages with senior leaders to escalate, inform, influence and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional partners or Health Authorities.
• The GSM leads complex submission and process improvement projects, making decisions independently and drives communication through collaboration with stakeholders and regulatory leaders.
• The GSM represents Regulatory Operational needs relating to Dossier Execution at Health Authority meetings, Industry discussions / initiatives.
• The GSM functions as a Submissions Management leader and change agent who can exhibit regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanor.
• The GSM leads efforts to change policies and strategies to meet evolving business needs.
• B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
• Significant hands on registration experience associated with development, maintenance, and commercialization activities within Regulatory Affairs
• Proven strength in leadership and decision making in ambiguous situations
• Demonstrated ability to engage and build strong collaborative relationships across multiple functions and levels of leadership. Excellent analytical and organizational skills are a prerequisite, as are excellent written and verbal communication skills.
• Expert knowledge of the processes, systems and regulatory guidance and a comprehensive understanding/knowledge of principles and concepts of other disciplines
• Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
• Multi-lingual skills desirable.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Out of hours and/or dynamic working hours will be required in line with business need. Domestic and International travel required.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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