Job Information
Boehringer Ingelheim Senior Regulatory Affairs Specialist in Sydney, AU, Australia
The Position
Reporting to the Head of Regulatory Affairs, AUNZ , an exciting opportunity has arisen for a full-time Senior Regulatory Affairs Specialist to come and join our high performing team!
Your role will be to 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, regional 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 and regional RA colleagues, including attending telecons with global and regional RA staff and participating in global activities where required
Requirements
Bachelor’s Degree – Pharmacology/Pharmacy, Biomedical or related field
Minimum of 5 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, regional and global colleagues
High standard of interpersonal skills, including the ability to mentor individuals, and collaborate with local, regional and global colleagues
Strong planning and time management skills
Customer-focused approach
What we offer
Boehringer Ingelheim offers a competitive remuneration and industry-leading lifestyle benefits including health insurance 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.
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
Human Pharma
Position Location
New South Wales
Organization
BI - Australia
Schedule
Full Time
#LI-BI
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.