Senior Regulatory Affairs Associate – Pharmaceuticals (The position has been filled)
Australia, Victoria
Full Time
15/03/2018
  • Take the Next Step in your Career with an ASX listed Australian Company
  • Professional, Friendly and Supportive Work Environment
  • Growing Company, Excellent Culture and Facilities, including onsite Parking

 

CLIENT

Our client is an established pharmaceutical company operating its manufacturing operation in Melbourne, Australia. Their products are Sold, Marketed and Distributed around the globe, including market leadership position in some existing markets. With a very clear purpose and vision, product pipeline and significant regulatory approvals expected in their developing markets, this company is set for significant growth.

Investment in new facilities has been very recently completed with some regulatory approvals already granted, and the remaining imminent. Manufacturing core products from this facility will significantly improve cost, quality & consistency, and support the sales growth projection in untapped markets.

 

ROLE

Due to internal movement, our client requires a Senior Regulatory Affairs Associate to join their Melbourne based team. Reporting to the Associate Director – Regulatory Affairs, this role will assist with the management of regulatory affairs for the Company’s pharmaceutical products.

You will ensure that your particular projects are completed on time and where needed, the provision of assistance with the development of structure and content for all technical documentation for submission and ultimate acceptance by various local/global regulatory bodies.

The ideal candidate will have a few years of regulatory experience with electronic submissions and direct interactions with global regulatory authorities, including TGA, FDA and EMA.  Not all these skills are mandatory.  

As the successful candidate, you will be able to balance the demands of regulatory affairs within a commercial landscape. You will have a high degree of initiative and will be able to operate with a high degree of autonomy as well as part of a team, exhibiting clear thinking and sound judgement.

Interpersonal communication skills are paramount for this role, including excellent written communication, due to the highly technical nature of the industry and the interaction with various regulatory agencies and commercial partners.

 

REQUIREMENTS

To be successful you will have a ‘can do’ attitude, proven track record and ability to be part of a champion team.

A summary of required criteria include:

  • Relevant qualifications in Science  – Degree as a minimum
  • A minimum of three years’ previous experience in Regulatory Affairs including dossier writing and preparation of regulatory submissions, preferably with pharmaceuticals
  • Experience in dealing with Australian, EU & US regulatory authorities in the medical device/pharmaceutical sector will be highly regarded
  • 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

 

APPLICATIONS

To discuss this excellent opportunity please call Helen on 03 9516 0100 or after hours on 0438 620 434. 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.