Senior Regulatory Affairs Specialist

Company description:

OUR COMPANY

At Boehringer Ingelheim 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 believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.

Job description:

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