Regulatory Affairs Expert

14 hours ago

Sydney, New South Wales, Australia PharmaLex Full time

Overview

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We are seeking a seasoned Regulatory Affairs professional to join our team as a Senior Consultant in Australia. The successful candidate will have extensive experience working with pharmaceutical and healthcare clients, ensuring compliance with regulatory requirements and maximizing commercial success.

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About the Role

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This role involves leading regulatory submissions and approvals for products, collaborating with global teams, and managing a team of skilled Regulatory Consultants. As a Senior Consultant, you will be responsible for advising clients on regulatory matters, developing strategic plans, and delivering results through effective project management.

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Requirements

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  • You hold formal qualifications in science or a related field and have at least 10 years' experience working in regulatory affairs, preferably in the pharmaceutical industry or consulting setting.">
  • You possess strong technical expertise in the Australian regulatory environment and have a track record of successful regulatory work spanning the entire product lifecycle.">
  • You have extensive experience in prescription medicines Regulatory Affairs within Australia and New Zealand, including new products such as Category 1 and New Medicine Applications.">
  • You have worked in leadership roles, demonstrating your ability to achieve results through people and develop a positive team culture.">
  • You are a natural problem-solver, critical thinker, commercially minded, and possess exceptional communication skills and stakeholder management skills.">
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What We Offer

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  • You will become part of a renowned team specializing in pharmaceutical regulation, sharing knowledge and expertise with colleagues.">
  • We offer a dynamic and inclusive work environment where you can build new skills and capabilities and grow your career.">
  • Our head office is based in St Leonard's, Sydney, NSW, Australia, with flexible working options available.">
  • A competitive estimated salary range is AUD $140,000 - $170,000 per annum, depending on experience.">
  • We welcome applications from candidates with diverse backgrounds and experiences.">
  • Please submit your application, including a cover letter and resume, detailing your relevant experience and qualifications.">
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Terms and Conditions

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Candidates must be based in Australia and have full working rights.

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