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Form of workPharmOut is a leading international consultancy, servicing the health sciences sectors including pharmaceutical, medical device, biologicals, pharmacy and blood and tissue manufacturing industries. We are looking for a director level leader to join our high performing team that is able to expand the services we offer.
We need an experienced Regulatory Affairs professional with a broad experience base to join our team, based in Melbourne.
We are looking for Regulatory Affairs professional who will be:
- On behalf of clients develop and implement strategic and operational plans for regulatory and scientific affairs activities
- Manage the preparation and maintenance of regulatory documents, including but not limited to INDs, NDA's
- Oversee regulatory submissions and respond to regulatory authority comments/requests
- Enhance the PharmOut ISO 9001 Quality Management Systems to include Clinical and Regulatory Affairs services
Applicants should have:
- Tertiary science or medical degree(s)
- At least 10 years' experience in a similar role preferably within a consultancy
- Previous Regulatory Affairs experience in the pharmaceutical and medical device industry. Ideally, the successful candidate will have previous experience in obtaining successful registration with EMA, TGA, PIC/S or US FDA
- Skilled in building robust relationships with internal and external stakeholders including health authorities.
- An entrepreneurial mindset and strong business acumen
- High level of integrity, self -driven and proactive
- Strong ability to think strategically and critically evaluate risks to regulatory activities and come up with innovative ideas to solve problems.
The following attributes would be highly regarded:
- Previous experience as a consultant
- Previous experience as a regulator
- Ability to provide oversight for device and drugs registrations
Want to know more? Apply now or visit our website at www.pharmout.net
Thank you to recruiters for not contacting us.
