getting prepared for the fda

7th Sept 2011
http://www.seek.com.au/Job/senior-director-regulatory-affairs/in/melbourne-melbourne/20613826

Note:

"have direct responsibility for the development of Biota's global regulatory strategy, positioning the company optimally for regulatory clearances and market acquisition in various jurisdictions".

Here's the full ad:

Senior Director Regulatory Affairs Highly successful Australian company

Expanding pharmaceutical development activity
New RA position: build the RA plans and function
Biota is an internationally renowned company and their highly successful medicinal drug discovery and product development work has resulted in a strong international profile.

The creation of this new leadership position in RA is a direct result of this success and the expansion of their development programs.

The Senior Director Regulatory Affairs will report to the VP Product Development and Strategic Marketing and have direct responsibility for the development of Biota?s global regulatory strategy, positioning the company optimally for regulatory clearances and market acquisition in various jurisdictions.

The RA team is small at the moment but this will grow as the development programs roll out. Your initial challenges will involve a review of Biota?s position in the current regulatory landscape followed by the development of a regulatory strategy to take into account the global regulatory environment and various important jurisdictions as well as Biota?s strategic goals.

Clearly this position demands a regulatory affairs executive with significant experience in medicinal drug development and experience dealing with several of the international regulatory jurisdictions.

We will also be looking for experience working with both clinical and pre-clinical teams. Whilst the development environment is anti-viral and the delivery mechanism is inhaled, this type of background would be of interest, but it is not a pre-requisite.