Job description
Regulatory Affairs Associate-228595
Regulatory Affairs Associate
OUR COMPANY
At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective.
Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative, and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.
THE POSITION
Develop, execute and maintain regulatory strategies for submissions in order to obtain/maintain regulatory approvals and regulatory compliance for assigned product(s) in line with Business strategies.
Tasks & responsibilities
- Analyze and/or assist in the analysis of scientific content of registration packages
- Prepare and submit regulatory submissions to the TGA/Medsafe or other associated regulatory bodies
- Review and approve artwork and packaging changes and recommend action
- Resolve regulatory issues/opportunities for improvement by problem solving and collaboration with local and corporate colleagues
- Keep up to date with government legislation as it relates to regulatory/ scientific affairs
- Actively train less experienced team members in regulatory related tasks, where appropriate
- Develop relationships with global RA colleagues, including attending telecons with global RA staff and participating in global activities where required
Requirements
- Bachelor’s Degree – Pharmacology/Pharmacy, Biomedical or related field
- Minimum of 3 years of experience in regulatory affairs with hands on Prescription Medicine experience writing a submission using the EU dossier
- Keen attention to detail
- Advanced computer skills, including competency in electronic submissions
- Highly developed written and verbal communication skills
- Ability to understand and communicate complex chemistry, non-clinical and clinical information to internal and external stakeholders
- Good relationship building skills, able to engage, communicate and negotiate effectively with customers and colleagues
- Good understanding of local regulatory regulations, with the ability to interpret requirements and engage in RA-related discussions with local and global colleagues
- High standard of interpersonal skills, including the ability to mentor individuals, and collaborate with local and global colleagues
- Strong planning and time management skills
- Customer-focused approach
WHY BOEHRINGER INGELHEIM?
With us, you can grow, collaborate, innovate, and improve lives.
We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth.
Who we are
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family-owned company, we focus on long term performance. We are powered by 50,000 employees globally who nurture a diverse, collaborative, and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com.au and join us in our effort to make more health.
What we offer
Boehringer Ingelheim offers a competitive remuneration package including flexible salary packaging options, and industry-leading lifestyle benefits including attractive leave options and a free and confidential Employee Assistance Program.
We want the best to apply!
Boehringer Ingelheim is a global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and foster an inclusive environment which benefits our people, patients, and communities.
How to apply
If you would like to be part of this highly driven and successful team, please submit your CV and a covering letter addressing the key criteria above.
You must have the right to live and work in this location to be considered for this opportunity.
As a pharmaceutical organisation, the health, wellbeing and safety of our employees, customers and communities is extremely important. As such it is a requirement that our employees be vaccinated, it is also a requirement any future employees be vaccinated.
Thank you for taking the time to consider a career opportunity with Boehringer Ingelheim. As part of our efforts toward continuous process improvement, you may receive a short survey pertaining to this recruitment process. We really appreciate your honest feedback. Thank you.
It is Boehringer Ingelheim's policy not to accept speculative resumes from Agencies, unless the role has been released directly to the agency. If we require your assistance on any roles, we will contact you at the time.
Position Area
Regulatory Affairs
Position Location
NSW – Sydney
Organization
BI Australia
Schedule
Full time
#LI-BI
Job - Medicine / Regulatory Affairs Primary Location - Africa, Asia, Australasia-Australia Organization - AU-Boehringer Ingelheim Pty Limited (Australia) Schedule - Full-time
