Senior Regulatory Affairs Associate – Part-Time

Senior Regulatory Affairs Associate – Part-Time

• Leading specialised Regulatory Affairs Consultancy since the 1990’s
• Strong values and reputation providing an inclusive, team based culture
• Part time role with flexible days and hours, working from home

 

About CS Executive Group

ChemSkill, the Regulatory Consulting Division of CS Executive Group has been operating since 1990. Our commitment to clients and the quality of work produced, has established ChemSkill with an excellent reputation as a well-respected Consultancy within the Industry.

ChemSkill specialises in the preparation and submission of applications, advice and recommendations for foods, therapeutics including complementary medicines, medical devices, cosmetics, veterinary chemicals and agricultural products under the corresponding Governmental Agencies (ie FSANZ, TGA, AICIS (NICNAS) and APVMA).

Due to growth, we are currently looking for an experienced Senior Regulatory Affairs Associate to join us on a part-time basis. Days and hours of work can vary and will be negotiated with the successful candidate. 

 

The Role

Key duties of the role include:

• Providing expertise and support to clients on regulatory matters relating to medical devices, complementary medicines and OTCs
• Product compliance review
• Label development and reviews for medicines and medical devices
• Generation and submission of regulatory documents
• Ingredient reviews

 

Selection Criteria

• As the successful candidate you will have completed a Bachelor of Science (Chemistry) or a Bachelor of Pharmaceutical Science or similar and have experience in the pharmaceutical / medical device industry
• Previous experience in a similar role with an emphasis on TGA regulations
• Experience with medical devices is a must

• Experience with the listing and registration of complementary and OTCs highly regarded

• Strong attention to detail

• A proven capability to project manage
• Commercially and customer driven problem solving

• In addition to taking ownership of your own day-to-day workload and responsibilities for project management, you must be willing to work collaboratively and share your knowledge within a supportive team environment

• A very high level of technical, communication, and interpersonal skills, with excellent written, oral skills and computer literacy

 

APPLICATIONS

To have a confidential discussion about this role please call Helen on 0438 620 434.

To apply, click the “Apply Now” button to submit your resume and also a brief covering letter addressing the above selection criteria.

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 those applicants being considered for shortlisting as candidates are contacted.