Regulatory Submission Specialist

7 days ago

Sydney, New South Wales, Australia PSI CRO AG Full time $90,000 - $120,000 per year

Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

PSI's business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies. We help our clients to generate data about safety and efficacy of medications and bring the best ones to market. By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life. Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients.

We offer an inspiring story of the company that has grown organically from a handful of countries to global presence. PSI is a mature company with standards and practices, but we do not stand still. Every day, there is a figurative Everest to climb, and you will not get bored here.

Job Description
Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.

We're looking for a Regulatory Specialist
on a 18-month contract
to cover maternity leave. This is a great opportunity for someone looking to gain hands-on experience in clinical research.

Office-based in Macquarie Park, Sydney

Your role:

  • Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export license applications.
  • Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters.
  • Review translations of essential documents subject to clinical trial submission.
  • Track the regulatory project documentation flow.
  • Review documents to greenlight IP release to sites.
  • Manage safety reporting to authorities.
  • Deliver regulatory training to project teams.
  • Assist with feasibility research and business development requests.

Qualifications

  • University degree or an equivalent combination of education, training and experience.
  • 2-3 years experience with clinical trial submissions in Australia.
  • Ability to learn, plan and work in a dynamic team environment.
  • Communication, collaboration, and problem-solving skills.
  • Knowledge of ICH-GCP guidelines and local regulatory requirements.
  • Experience in preparing and reviewing regulatory submission documents.
  • Strong organizational skills and ability to manage multiple projects simultaneously.
  • Excellent time management skills to meet tight deadlines.
  • Ability to interpret and apply complex regulatory guidelines.
  • Willingness to stay updated on changing regulations and industry trends.

Additional Information
This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.

What you'll get:

  • Competitive salary
  • We offer hybrid work arrangement - 2 days flexi and 3 days in office
  • Access to a wide range of employee benefits
  • Additional 5 days of wellness leave
  • Development and learning opportunities
  • Chance to make a real impact in a meaningful industry

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