Regulatory Affairs Director

3 weeks ago

Sydney, New South Wales, Australia PharmaLex Full time

Your Opportunity

We are seeking an experienced Regulatory Professional to join our Pharmaceutical Regulatory Consulting team in Australia. In this role, you will have the opportunity to work with a broad range of clients, predominantly in the pharmaceutical and healthcare sectors. Your primary objective is to maximize client commercial success by ensuring appropriate licensing, marketing, and regulatory compliance of client products.

Your Key Responsibilities

  • Advise, support, and manage regulatory submissions and approvals for products, including liaising with clients and regulatory teams and third-party subject matter experts.
  • Liaise proactively and work collaboratively with global, regional, and local colleagues.
  • Lead a team of highly skilled Regulatory Consultants and work together to achieve the best outcomes for our clients and ultimately the patients we serve.

Your Profile

We are looking for a candidate with formal qualifications in science or a similar field and a minimum of 10 years' experience working in regulatory affairs either for prescription products in industry or a consulting setting. You should be recognized as a technical expert within the Australian regulatory environment, with a strong track record of regulatory work spanning the entire product lifecycle.

We Offer

  • By joining the PharmaLex Australia team, you will become part of a team renowned as specialists in our field. You will work closely with experienced Senior Managers, Associate Directors, and Directors who have extensive consulting experience.
  • We are committed to creating a culture where we all feel valued and heard, and a place where we can all build new skills and capabilities and grow our careers.
  • We offer a range of flexible working options, including varying start and finish times and hybrid working. We are a diverse workplace and welcome experiences from other countries and settings.

Please submit your application, including a cover letter. Applicants must be based in Australia and have full working rights.

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