Manager, Global Regulatory Strategy US & Canada (Batavia)

Employment Type

: Full-Time

Industry

: Non-Executive Management



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The Manager, Global Regulatory Strategy US & Canada implements regulatory strategies and priorities in conjunction with Global Regulatory Lead (GRL) and Global Regulatory Product Team (GRPT) colleagues, as appropriate. Identifies and obtains data needed and ensures all is effectively presented for submissions to Health Authorities. Manages the regulatory submission and approval process and serves as liaison with Health Authority for routine communications in support of filings. Ensures within its region the application of established policies and best practice regulatory standards for all filings, maintenance of existing product registrations and agency interactions. Assists Regulatory Staff by identifying and providing data needed to support filings, responses to HA inquiries and registration maintenance. This position may develop and supervise others.

Key Responsibilities Include:
  • Assesses R&D programs against regional specific regulatory requirements
  • Influences internal customers on Regulatory Health Authority issues including commercial, public affairs, clinical development, legal, and others who contribute to regulated communication
  • Manages the preparation and review of regulatory submissions consistent within Regulatory requirements and guidelines and assures complete and timely response to Health Authority during application review
  • Represents A&A on Global Regulatory Product Team (GPRT) and ADTs as appropriate. Advises on regional specific requirements and provides strategic input.
  • Serves as Health Authority liaison and interfaces with Health Authority for meetings, teleconference, etc. Coordinates preparation of Health Authority meeting briefing packages
  • Demonstrates good negotiation skills and builds consensus. Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
  • Recommends and implements changes to complex projects based on knowledge and expertise, accurate interpretation of government regulations, guidances, corporate policies and management related considerations.
  • Disseminates/presents pertinent information to appropriate cross-functional areas.
  • Employs logic and methods to independently and effectively/creatively solve difficult problems. Uses problem solving skills to separate and combine tasks into efficient workflow.
  • Assures that established policies and standard interpretation of regulations are communicated and followed for assigned projects. Provides regulatory direction regarding marketed products and products in development to support the development of compliant and competitive programs.

  • Required Education: Bachelor's degree (pharmacy, biology, chemistry, pharmacology) or industry related experience.
  • Preferred Education: Advanced Degree a plus. Certifications a plus.
  • Required Experience: 6 years industry related, Regulatory or R&D experience.
  • Proven skill at implementing successful global regulatory strategies.
  • Experience working in a complex and matrix environment. Good communication, both oral and written.
  • Preferred Experience: 2-3 years' experience in pharmaceutical regulatory activities.
  • Experience interfacing with government regulatory agencies.

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