Senior Consultant

3 days ago

Sydney, New South Wales, Australia Pharma To Market Pty Ltd Full time $120,000 - $150,000 per year

Pharma To Market is an award winning life sciences consulting company specialising in regulatory affairs and pharmacovigilance services. With offices in Australia, Singapore, Malaysia, Thailand and Vietnam, it is entrusted by some of the world's leading pharmaceutical and medical device companies. We believe that establishing relationships built on trust, transparency and reliability are at the core of our and our clients' success.

We are looking for an experienced Senior Consultant in Regulatory Affairs to join our dynamic and enthusiastic team on a fixed 12-month contract.

You will be responsible for managing and driving regulatory submissions and approvals for a portfolio of pharmaceutical products. The role requires regulatory strategy and technical CMC expertise with prescription medicines (including generic products and new entities) and biotechnology products

The ideal candidate must have:

  • Experience in the preparation and submission of dossiers for prescription pharmaceutical products.
  • The ability to determine the most appropriate regulatory strategy for applications to TGA and Medsafe.
  • Experience in alternative and expedited regulatory pathways.
  • Strong technical CMC knowledge.
  • Experience liaising with regulatory authorities and internal and external regulatory personnel.
  • The ability to develop and maintain effective working cross-functional relationships.
  • Strong customer service skills and be achievement driven.
  • Tertiary qualifications in life sciences and have at least seven years' experience in regulatory affairs. Experience in a consulting role will be highly regarded.

The primary responsibility of this role is to prepare and review regulatory applications for prescription medicines for submission to the Therapeutic Goods Administration and Medsafe. As a capable project manager, you will be responsible for coordinating activities with clients and other third parties to prepare applications within agreed time frames and in compliance with relevant regulatory requirements.

You must be able to develop collaborative relationships, have good decision making skills and have demonstrated project and time management skills. The role requires a high level of attention to detail with an ability to have perspective on the 'big picture'. Good oral and written communication skills, analytical problem solving skills and strong IT skills are also required. In return for your commitment to this role, you will be rewarded with an attractive remuneration package.

Please note: whilst this business operates from Brisbane, this role may be fulfilled from anywhere within Australia. However, you must be eligible to work in Australia.

Please complete the seek application process and ensure that you provide a Cover Letter including your capability and capacity to work remotely for the role from anywhere in Australia.

If you are an enthusiastic and self-motivated regulatory affairs professional with a drive to learn new skills and to succeed, this is the position for you

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