Role Description:

The Consultant works within the Regulatory, Quality & Compliance team delivering a range of regulatory applications within Australia, New Zealand, Japan, and the Asia Pacific (APAC) region. The Consultant manages client projects, working closely with other members of the team, to deliver a superior client experience, optimize project outcomes, and contribute to the culture and capabilities of the team.

Role Responsibilities:

General:

  • Adherence to ProductLife Group’s values, policies, and quality management systems.
  • Provide high-quality work that contributes to client satisfaction and loyalty, leading to the optimization of repeat business and expansion of service provision across the Regulatory, Quality & Compliance service offering.

Project & Client Management:

  • Support regulatory activities requiring a sound knowledge of the type and quality of chemistry, manufacturing and controls (CMC), and clinical and non-clinical evidence necessary to support new medicines registrations and medical device inclusions, related life cycle management, and maintenance activities.
  • Provide support to clients on the registration and listing of pharmaceuticals and biologicals.
  • Review, critically evaluate, prepare, and submit regulatory dossiers to the regulatory agencies.
  • Participate in assigned projects and support project teams as requested.
  • Act as a subject matter expert.
  • Review and quality control (QC) applications, regulatory, quality, and compliance documentation as required.
  • Assist in the preparation of literature-based submissions, including the preparation of associated overviews and summaries.
  • Assist clients in responding to regulatory agency questions.
  • Assist clients with the maintenance of current registrations, listings, and inclusions.
  • Prepare and submit safety-related updates to Product Information documents at varying levels of complexity.
  • Attend meetings/teleconferences with clients and/or regulatory agencies as required.
  • Liaise with other groups within ProductLife Group as required.
  • Lead contributor to client retention by developing strong relationships with existing clients and providing high-quality consulting services to build client satisfaction and loyalty, leading to the optimization of repeat business and expansion of service provision across the business unit’s service offering.

Qualifications / Experience / Skills:

  • A bachelor’s degree in science, pharmacy, or a related discipline.
  • A minimum of 5 years’ experience in regulatory affairs, preferably in a commercial environment.
  • Experience in the review, critical evaluation, and presentation of clinical data.
  • Good knowledge of legislation, regulations, guidelines, and working procedures within Australia, New Zealand, and the JAPAC region.
  • High-level written and oral communication skills.
  • Proven problem-solving and project management skills.
  • Reasonable computer literacy.
  • Ability to deal with a high level of confidentiality.
  • Post-graduate qualifications in a relevant discipline are desirable.
  • Previous experience in project management and/or consulting.

Consultant (RQC) – VAF 153

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