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Senior Regulatory Manager, Innovation & Strategy, Personal Health Care
The P&G Health Care strategic priorities includes four core categories of products with both Global Brand Franchises and Regional Product Portfolios across Nerve Care, Pain, Vitamins and Cough & Cold. Products within these portfolios include medicines, food supplements, medical devices, vitamins, health food and cosmetics.
The opportunity will see you act as the regulatory representative for specific global or regional initiatives within a Brand Franchise and as a strategic business partner to build bigger and better initiatives. You will act as Brand Franchise Ambassador and point of contact for regulatory colleagues globally. You will actively monitor the Regulatory External Environment assessing impact of changes on the Brand Franchise initiatives.
We have opening for two experienced roles with opportunities to lead global and regional regulatory strategies for key projects and initiatives across the different healthcare brands.
Key Responsibilities Include:
·Develop and clearly communicate regulatory strategies that identify requirements for launch and outline data needs to guide Research & Development (R&D) activities, working in close collaboration with local country regulatory, R&D, Manufacturing / Technical Operations and Commercial teams
· Lead Global Dossier development liaising with Corporate technical functions and vendors to obtain quality documentation in support of our product applications
· Lead preparation, compilation and review of Global product dossiers for registration / launch in accordance with in-house standards and current legislation
· As appropriate, co-ordinate resource effectively ensuring that high quality documentation is available in a timely manner and meets specified project timelines/milestones
·Provide strategic input into Global Product labeling, promotional Material (Toolboxes) and Digital Copy development and approval to enable commercial activation of product launches.
· Assess the impact and implementation of required company compliance with all regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labeling and production of our products.
· Provide coaching to junior colleagues or new comers to the team
·PhD, Masters or Bachelors' degree in Chemistry, Life-Science or related fields
·Extensive experience preferably in consumer health and across multiple regulatory classification areas (medicines, medical devices, food supplements etc)
·Experience developing regulatory strategies for successful launch of new products ideally across different countries/geographies.
·Capable of solving complex problems and applying analytical thought and judgement.
·Demonstrated ability to work independently in a matrix environment to build superior relationships with stakeholders
·Experienced user of electronic document management systems
·Strong initiative and follow-through with accountability for work quality, attention to detail, communication and presentation skills
·Results oriented and self-motivating with an ability to influence others
·Demonstrated ability to handle competing priorities effectively with excellent organizational skills
·Commercial understanding of corporate and operational business issues
·Openness to change and ability to think out of the box
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