Allemagne 13.10.2021

Innovation Regulatory Affairs Manager

Tasks

AIXIAL is an international Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany, Scandinavia and Czech Republic.

We are currently hiring in Germany an:

Innovation Regulatory Subcategory Lead (m/w/d) - Home-based position

Your responsibilities include (but are not limited to):

  • Be in charge of the strategic and operational regulatory affairs activities for a portfolio of a major global brand including multi-regional pipeline development and marketed products of the category.
  • Be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the category global business strategy.
  • Substantially drive the pipeline development strategies in alignment with the business strategy including early stage operational responsibilities
  • Contribute to the development of the regulatory strategy for the respective portfolio, working collaboratively with the global regulatory office community and cross functional teams to create project plans that identify opportunities, regulatory risks and mitigation strategies
  • Provides regulatory strategy and intelligence for due diligence and business development initiatives
  • Be a strategic partner for and work closely with the Scientific Innovation team for their sub-category & align with them on prioritized innovation projects
  • Coordination of the preparation and on-time delivery of compliant submissions to Regulatory Agencies and for managing responses to Regulatory Agencies questions
  • Follow up of the implementation of the global strategy with regulatory affairs in affiliates
  • Ensure timely execution of agreed regulatory milestones for the development projects

Requirements

  • A Master Degree, Pharm D, MD, PhD
  • Minimum 10 years in Regulatory Affairs, including leadership roles, and experience managing, and leading global team required
  • Proven track record in development and execution of regulatory strategies, preferably with significant experience in OTC medicinal products, medical devices and food supplements including pipeline development, due diligences, drug development
  • Extensive knowledge of laws and regulations affecting the global healthcare industry
  • Recognized expert in managing global matrix teams and partnering with cross functional teams at a highly strategic level
  • Experience living in different global regions/ countries desirable
  • Fluency in English
  • Strong analytical thinking, action planning and organizing
  • Team spirit, persuasiveness & influence, highly collaborative with all cross functional partners
  • Ability to be flexible and adapt quickly to changing strategies and priorities
  • Excellent communicator both written and verbal, especially in group
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