Strategic Regulatory Affairs Professional

5 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $150,000
Job Opportunity

We are seeking an experienced professional to join our team in Regulatory Affairs. As a Manager, Regulatory Affairs, you will be responsible for working with local regulatory affairs departments, cross-functional teams, and global functions to define and implement regional strategies for assigned products.

The ideal candidate will have a strong understanding of regional and local requirements, as well as experience in preparing documents for health authority submissions. They will also be able to communicate effectively with senior-level management and possess excellent verbal and written communication skills.

Key Responsibilities
  • Regulatory Strategy and Expertise: Understands regional and local requirements and advises the Global Regulatory Team (GRT) and Compound Development Team (CDT) on applicable regulatory requirements, guidelines, and processes.
  • Participates as a standing member of the project-related GRT if applicable; supports the GRT by providing strategic regional input into registration and life cycle management.
  • Expedites commercialization of new indications and line extension by providing regional regulatory inputs to identify barriers and needs.
  • Provides guidance to local affiliates on development of strategies to accelerate submissions/approvals.
  • Provides input in post-registration activities, including labeling changes. Provides regional implementation and regulatory-based advice on new and updated Core Data Sheets.
  • Maintains expert knowledge in regional regulatory requirements and ensures staff are expert in country and product-specific regulatory requirements.
  • Provides AP evaluation in licensing activities.
Requirements
  • Minimum of bachelor's degree or equivalent in pharmacy or life-science or health-related discipline.
  • 6-10 years of overall experience in the pharmaceutical industry and preferably regulatory experience.
  • Hands-on experience in pharmaceutical product registration in AP countries and familiarity with AP regulatory systems and product registration requirements preferred. Experience in preparing documents for health authority submissions (Chemistry & Manufacturing, and/or Registration dossiers) preferred.
  • Demonstrated ability to handle multiple projects and strong organizational skills.
  • Ability to communicate to senior-level management and working knowledge of regulations in the region.
  • Experience in HA interactions.
  • Excellent verbal and written communication skills – proficiency in written and oral English; Mandarin/Asian languages preferred.
  • Ability to develop and maintain excellent working relationships; able to work in a team environment and as an individual contributor.
  • Cultural sensitivity and ability to work in a multi-cultural, matrix environment; proactive, flexible, and able to adapt to changing regulatory environments.
  • Proficient use of MS Office and Internet resources.
What We Offer
  • Opportunity to work with a global company in a dynamic and fast-paced environment.
  • Collaborative and supportive team culture.
  • Competitive compensation and benefits package.

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