Provides an interface to Regulatory partners within designated Business Units, offering project leadership and operational expertise in the logistics involved with execution of regulatory submissions to regional partners and selected Health Authorities. Contributes to budget/cost center management.
• The GSM will guide and advise the Global Asset Team on FDA and EMA guidance and policies as related to publishing, document links and requirements for format construction and organization of dossier build and will raise awareness of important factors to consider when developing Marketing Applications.
• Working on behalf of the Regulatory Lead, the GSM provides project (submission) management to the Global Asset Team from 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.
Responsibilities
• 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 day-to-day direction to Publishing Managers so that dossiers can be prepared and managed appropriately throughout Pfizer 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 implications of product strategy with regards to new Marketing Applications and approvals, 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.
• 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
Qualifications
• B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); 10 years of 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.
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