Our client is a highly respected leading biotechnology company with excellent facilities and a friendly, supportive work environment. Due to an increasing workload as the company’s portfolio of products grow, they are seeking an experienced Regulatory Affairs Specialist to join their Quality and Regulatory Affairs team.
This role will contribute to the management of regulatory affairs for medical devices and pharmaceuticals to ensure that products are delivered in full, and on time, including all requisite activities, which include: risk assessments; development and maintenance of documentation; strategic planning for global submissions of new and already approved products; submission and acceptance by the relevant regulatory bodies in applicable jurisdictions.
As the successful candidate, you will be able to balance the strategic demands of regulatory affairs within the commercial landscape along with the detailed regulatory submissions for relevant geographies and regulatory bodies. You will have a high degree of initiative such that you can operate with a high degree of autonomy and act as an enabler for the business.
Interpersonal communication skills will be paramount for this challenging role, including excellent written communication, due to the highly technical nature of the industry and the interaction with various regulatory agencies, commercial research partners and suppliers all around the world.
To be successful in your application you will need to meet the following criteria:
To discuss this excellent opportunity please call our team on 03 9516 0100. To apply, please click the ‘Apply Now’ button. Please ensure you attach a Resume and Cover Letter in Word Format addressing the full selection criteria.
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