Randstad has been given the opportunity to support one of our flagship clients in the Pharmaceutical space, who are currently recruiting a key position of Regulatory Affairs Project Manager, to be based in central Melbourne.
This role gives you the opportunity for progression within this growing organisation, dealing with national and International teams, based from the client's site here in central Melbourne.
The main purpose of the role is to support the International Regulatory Affairs management team across the wider business, with key focus on -
... - Preparation and submission of marketing authorization applications in International markets, including Australasia, Europe and the USA.
- Obtaining regulatory approvals internationally for designated product portfolio
- General regulatory advice to senior team for designated product portfolio
- Manage national regulatory commitments and submissions
Further Key focus -
- Update documentation as required in response to Regulatory Agency comments/questions
- Maintain awareness of regulatory legislation and guidelines in EU, US and other relevant markets
- Apply for MA, variations and annual update reports in Europe including CH
- File substantial amendments as required
About you -
- Post-graduate qualifications in Pharmacy, Biological Sciences, or related discipline
- Biological/medical education/knowledge
- Working knowledge of international regulatory standards in the areas
of quality, safety and efficacy - Negotiation skills
- Excellent attention to detail
- Ability to plan, organise and follow up with a minimum of supervision
- Strong willingness to learn
- Ability to work in a team environment
- Flexibility to adapt to a small company’s multiple task requirements
- Effective verbal and written communication in individual and group settings
- Research skills (ability to source information and to review regulatory legal background)
Sound like the perfect fit for you? Directly apply now or contact Alessandra by email - alessandra.hernandez@randstad.com.au .
I’m looking forward to hearing from you!
At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.
