Strategic Regulatory Specialist

1 day ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $110,000 - $187,000
Strategic Regulatory Specialist

Pfizer's dynamic regulatory landscape necessitates a highly skilled and knowledgeable team to navigate intricate requirements and ensure optimal patient care.

Main Responsibilities
  • Represent the organization as an approval liaison in the regulatory affairs department.
  • Provide strategic product direction to teams while interacting with regulatory agencies and negotiating for expedited approval of pending registrations.
  • Act as the regulatory liaison on project teams throughout the product lifecycle and provide regulatory representation to marketing or research project teams and government regulatory agencies.
  • Develop submissions, progress reports, supplements, amendments, and periodic experience reports leveraging regulatory expertise.
  • Guide operational teams in managing projects, prepare forecasts for resource requirements, and identify areas for improvement.
  • Advance new concepts and methodologies through comprehensive knowledge of principles, concepts, and theories of the discipline.
Required Skills and Qualifications

The ideal candidate will possess excellent communication skills, strong analytical abilities, and a deep understanding of regulatory affairs principles. Proficiency in negotiation and project management is also essential.

Benefits

This role offers a unique opportunity for professional growth and development within a dynamic and fast-paced environment. The successful candidate will be part of a collaborative team that values innovation and excellence.

Others

Please note that this position requires flexibility and adaptability. The ability to work effectively in a team environment and prioritize tasks efficiently is crucial for success in this role.

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