Director - Biopharmaceutical Regulatory Affairs


Director - Biopharmaceutical Regulatory Affairs
Job type
Ethical Pharmaceuticals
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Bringing biopharmaceutical products to market requires specialist expertise, technical brilliance and a focus on excellence.  We provide Strategic Regulatory Affairs advice and authoritative scientific guidance during the Product Development process, to help our clients realise the commercial value of their innovation.

For 25 years, our partnerships, ranging from the largest pharmaceutical companies to biotech start-ups, academia and investment groups, have facilitated expedient approval for therapeutic products in Europe, the USA and Australasia. We are the internationally recognised specialist in the design of regulatory strategies for biological products, cell and gene therapies, innovative NCEs and biomarkers. Our consultants have unrivalled technical knowledge, exceptional scientific expertise and deep working relationships with key regulatory agencies.  Our cornerstone Australian operation has been integral to servicing the growing demand for our consultancy expertise with an expanding group of global clients.

We are actively seeking to appoint an executive regulatory consultant to a leadership role within our well established team and ensure future succession planning. We welcome interest from regulatory strategy specialists to provide expert guidance on biologics CMC, clinical and nonclinical development programs, and author and prepare regulatory agency submissions.  

Ideal applicants will engage seamlessly with client stakeholders, effectively contribute within a collaborative global team dynamic, and demonstrate exceptional verbal and written communication skills particularly relating to preparation and review of documentation. Preferred applicants will hold postgraduate qualifications in Science and/or Medicine and we anticipate technical expertise will span molecular and cell biology, protein biochemistry, immunology and / or pharmacology.

Significant career development and leadership opportunities are available to individuals who positively impact the success of our clients and our business.

Please note this position is located in Brisbane, the state capital of Queensland, Australia’s second largest state and home to 5m people. Known as the Sunshine State and globally renowned for its natural beauty, Queenslanders enjoy an enviable, cosmopolitan lifestyle and access to leading academic and medical research institutions, cultural amenities and sports entertainment.

Jason Borrie from HPM Executive is managing this appointment on our behalf.  If you would like to schedule a confidential discussion regarding your interest in this role, please email to coordinate a time.  
ERA Consulting UK LTD