Regulatory Affairs Manager
- Experience Level
- Experienced (non-manager)
- Unique opportunity to manage regulatory functions
- Be part of a collaborative and high performing team environment
- Competitive salary with flexible working arrangements
What you can achieve in the Position
Joining the team in this recently established role, you will enjoy the responsibility of advocating proactive regulatory management for QBiotics Group, achieving both operational efficiency and meeting applicable industry compliance standards.
Working collaboratively with the CMC and Quality teams, you will ensure lifecycle management and obtain marketing authorisations in new regions. Specific responsibilities include:
- Preparing regulatory submissions including but not limited to; marketing authorisation, IND/IMPD and variation packages, in line with regulatory requirements
- Assessing proposed changes and deviations for regulatory implications
- Liaising with regulatory agents and consultants in various regions
- Supporting implementation of compliance strategies and plans
- Drafting compliance and regulatory policies and procedures, and maintaining regulatory registers
What you will bring to the Position
With relevant qualifications in an appropriate scientific discipline, you will demonstrate experience in managing complex projects within the pharmaceutical or biotech industries and at least 5 years of experience in pharmaceutical regulatory management. You will also demonstrate an in-depth understanding of product lifecycle management and regulatory framework in the US, EU, Australia, and other regions for medicines.
As a proactive individual, you will be persuasive, strategic, and flexible, with the ability to build and maintain successful working relationships across a range of stakeholders. Your highly effective communication and interpersonal skills, with the proven ability to support teams in the generation of ideas and opportunities and turn them into positive results, will see you thrive in this interesting and fulfilling role.
Assistance with relocation may be provided where the successful applicant is located outside of South-East Queensland.
At QBiotics, ethics-based values and culture underpin long-term business success and responsible corporate citizenship. They are embedded into all aspects of our business and promote sustained creativity, productivity and excellence in business performance.
We have an organisational structure which fosters collaboration, innovation and delivering investor return. We believe in supporting the growth of our people and seek opportunities for both the personal and professional development of our team.
Our culture is team-based, collegial and fun. We are a growing team and we are focused on maintaining our culture and values as we expand. We aim to be true, passionate and purposeful about what we do and to celebrate being innovative and different.
How you apply
Please send your resume and a cover letter outlining your suitability for the role to firstname.lastname@example.org. Please include the reference RAM0221 on your application.
Applications close on Friday 26 February 2021, to be reviewed in early March 2021.