Regulatory Affairs Specialist – Pharmaceuticals & Medical Devices (The position has been filled)
Australia, Victoria
Full Time
07/10/2016
  • Permanent Full Time Role with an Innovative Biotech Company
  • Further your Career in Supporting an Industry Leading R&D Technology Agenda
  • Excellent Facilities and a Culture Positively Fostering Trust, Integrity, Innovation & Teamwork

 

CLIENT

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.

 

ROLE

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.

 

REQUIREMENTS

To be successful in your application you will need to meet the following criteria:

  • Minimum of a BSc in Biochemistry, Pharmacology or similar
  • At least ten years’ experience in Pharmaceuticals and Medical Devices; including Regulatory submissions for Medical Devices and Pharmaceuticals across relevant geographies and regulatory authorities
  • Good experience in compiling and maintaining technical files such as: Design History Files (DHF); Device Master Records (DMR); Device History Records (DHR); and Common Technical Documents (CTD)
  • Development and execution of regulatory strategies, including project planning and implementation
  • MUST have a good eye for detail, superior written communication skills, be a good team player and a problem solver
  • Ability to identify, analyse and manage risks associated within areas of responsibility and expertise
  • Awareness of and compliance with Occupational Health and Safety legislation
  • Key to this role will be your flexible “can do” attitude, excellent work ethic and initiative whilst working autonomously but as part of a team

 

APPLICATIONS

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.

 

THANK YOU

Thank you for taking the time to apply for these roles. As we receive a large number of applications every day, we can only contact short-listed candidates. If you do not receive a call from our Recruiters, then your details will remain on our database for future suitable roles.