We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.


Regulatory Affairs Associate / Senior Associate

We have an opportunity for a Regulatory Affairs Associate or Senior Associate to join our Pharmaceutical Regulatory Consulting team in Australia.  Internally the position’s title is Manager, Regulatory Affairs.  In this role you will have the opportunity to work with a broad range of clients, predominantly in the pharmaceutical and health care sectors.  Your primary objective is to maximise client commercial success by ensuring appropriate licensing, marketing and regulatory compliance of client’s products.  In this role, you will advise, support and manage regulatory submissions and approvals for products, including liaising with clients and regulatory teams and third-party subject matter experts.   At times you will act as the authorized agent to coordinate and lead pre-submission meetings and other key meetings with Health Authorities

Your Profile

  • You have formal qualifications in science or similar field and a minimum of 5 years’ experience working in regulatory affairs either for prescription products in industry or a consulting setting.  
  • You will have exposure with Australian and New Zealand regulatory environments with extensive hands-on experience in the preparation of regulatory submissions with a strong track record of success. 
  • You are a natural problem-solver, commercially minded, and exceptional communication skills and stakeholder management. You thrive on diversity and challenge and can effectively prioritise and manage several projects at once. 
  • You are a team player and enjoy collaborating with your peers to deliver to client’s expectations.  
We Offer
  • By joining the PharmaLex Australia team you will become part of a team renowned as specialists in our field. Sharing knowledge and expertise with others is part of every day.  You will work closely with experienced Senior Managers, Associate Directors and Directors who have extensive Consulting experience.
  • We offer a range of flexible working options including part time, varying start and finish times and remote working from home.  
  • Whilst we are serious about our business we don’t take ourselves too seriously and aim to create a fun team environment where all can thrive.
  • Our head office is based in St Leonard’s, Sydney, NSW, Australia.

If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

For further information please don’t hesitate to contact us:

Jennie Brandenburg, Senior Manager, Human Resources Australia


Agencies only by prior agreement for the specific job opportunity.