Regulatory Affairs Specialist

Regulatory Affairs Specialist

• Full time opportunity with a growing Australian biotech company
• Assist with the registration of products in global markets
• Experience with CMC and FDA highly regarded

 

CLIENT

Our client, a growing biotechnology company and a leader in their field, is based near Melbourne’s CBD. Due to continued growth in global markets, they require a Regulatory Affairs professional to join their team. This presents a wonderful career opportunity for someone wishing to expand their skills and join a supportive and dynamic environment.

 

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
• Five years of regulatory experience in Pharmaceuticals and/or Medical Devices;
• 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 relevant registration documents is essential;
• Previous experience in the compilation and management of Common Technical Documents;
• Solid project management skills and experience with the execution of regulatory strategies;
• Excellent written and verbal communication skills as well as excellent problem solving skills and attention to detail;
• As with all regulatory projects you must be able to assess risks associated with your projects;
• Awareness of and compliance with Occupational Health and Safety legislation
• Must be able to attend occasional national and international meetings;
• Self-motivated with the ability to work effectively both independently and within a team;
• You must have a flexible “can do” attitude, excellent work ethic and initiative.

 

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.