Regulatory Affairs Specialist – CMC, Pharmaceutical and Medical Devices
Australia, Victoria
Full Time
27/03/2019
  • 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 leading ASX-listed biotechnology company with a proven technology platform that is being applied in a wide range of industrial and healthcare applications for the development of innovative products.

Our client values motivated, results-oriented people who will enjoy the opportunities and challenges this dynamic and high-performance environment offers. As part of their team, you will work closely with other talented and committed professionals. The company consistently recruits for technical excellence, enthusiasm and a strong commitment to collaboration and teamwork.

 

ROLE

This role will contribute to the management of regulatory affairs, with a focus on CMC aspects, for medical devices and pharmaceuticals to ensure that products, including marketed products, are delivered in full, and on time, addressing all requisite activities, which include: development and maintenance of high quality technical information and regulatory submissions; strategic planning for and support of global submissions of new and already approved products; addressing queries from relevant regulatory bodies in applicable jurisdictions; change control; and risk assessment.

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 address the following criteria:

  • Minimum of a BSc in Chemistry, Biochemistry, Pharmacology or similar
  • At least ten years’ experience in Pharmaceuticals and/or Medical Devices; including Regulatory submissions for Medical Devices and/or Pharmaceuticals across relevant geographies and regulatory authorities
  • Experience in change control and technical transfer activities relevant to the CMC and regulatory environment highly regarded
  • An understanding of the compilation and maintenance of technical files such as: Design History Files (DHF); Device Master Records (DMR); Device History Records (DHR)
  • Experience in writing and lifecycle management of Common Technical Documents (CTD)
  • Experience in the development and execution of regulatory strategies, including project planning and implementation
  • MUST have a good eye for detail, superior written and verbal 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
  • Ability to travel domestically or internationally as required
  • Key to this role will be your flexible “can do” attitude, excellent work ethic and initiative whilst working autonomously, but as an integral part of a small team

 

APPLICATION

For a confidential discussion about this exciting opportunity please contact Helen Patronis during office hours on 03 9516 0100. After hours please call 0438 620 434.

To apply for this role, please click the ‘Apply Now‘ button then send your current resume and a covering letter addressing the above selection criteria to CS Executive Group.

 

THANK YOU

CS Executive Group would like to thank you in advance for taking the time to apply for this role. Unfortunately, due to the large volume of correspondence our recruitment team receives on a daily basis, we genuinely cannot respond to each application – only individuals being considered for shortlisting as candidates are contacted.

However, if on this occasion you’re unsuccessful, please note your details will be added to our Talent Pool database. This means is that in future you may be contacted by one of our team of recruiters for other suitable roles.