2022 Regulatory Affairs Associate null

About Pfizer

Pfizer is one of the world’s leading biopharmaceutical companies, with a portfolio of some of the world’s most well-known medicines, vaccines, and therapeutics. They advance medical innovation and distribute medicines that might not otherwise be available to underserved communities.

Your role

The primary responsibility of this role is the regulatory management of the assigned portfolios undertaking regulatory submissions and maintenance activities for both Australia and New Zealand.

How will you achieve it?

• Ensure regulatory submissions are approved within timelines defined by the Pfizer Australia/New Zealand Operating and Strategic Plans consistent with Health Authority processes
• Ensure maintenance of in-line products by carrying out all regulatory activities associated with change control processes for labeling, CMC, and artwork
• Ensure maintenance of inline product by carrying out all product lifecycle regulatory activities
• Work with Regulatory Affairs Manager or more senior colleagues (as assigned by the Manager) to develop acceptable regulatory strategies for submissions
• Manage interactions with Regulators and build productive collaborative relationships with relevant TGA/Medsafe personnel
• Build productive collaborative relationships with relevant Global Regulatory Leads
• Scan regulatory environment, identify and assess the impact of new/emerging guidelines for Regulatory, Pfizer Australia, and the wider Pfizer Organisation
• Where needed, contribute to Departmental initiatives and/or project teams.

Training, development & rotations

They’ve transformed growth and development at Pfizer to ensure that everyone can follow the path to their dream career, whether that’s climbing a traditional, vertical ladder – or as they like to call it – ‘zig-zagging’ their way to a new role. Growth at Pfizer isn’t linear, success isn’t limited and advancement opportunities are abundant. Read more.

Salary & benefits

Roles in the R&D and Manufacturing industry may earn an average of A$62,000 to A$71,000. (Source: Prosple Salary Guide)

Pfizer offers competitive compensation and benefits based on a variety of factors including prior experience, geographic location, and talent pool availability. This includes:

1. Pay for Performance Philosophy and Practices
2. Benefits to Maintain and Promote Health and Wellness
3. Benefits to Help Colleagues Meet Financial Goals
4. Breakthrough Benefits for the moments that matter
5. Read more.

Career progression

Pfizer actively encourages you to have growth conversations about your career with your manager and explore internal development opportunities. They’ll help you to open doors, provide you with the tools you need to thrive, and encourage you to explore the world that sits outside your comfort zone. Read more.

Work life balance

Pfizer offers colleagues health and wellness programs that help them maintain and promote optimum health and wellness. Whether you’re caring for your children, your spouse/partner, your parent(s), another loved one, or yourself, Pfizer provides resources and time off to help. Read more.

Culture & vibe

Pfizer realizes that delivering on its purpose means not just attracting the best and brightest talent but also ensuring its colleagues can thrive in an environment and culture where they champion diversity and inclusion. They believe that every person deserves to be seen, heard, and cared for, and they work to further this goal by bringing together people with different backgrounds, perspectives, and experiences. Read more.

To know more about Pfizer's culture, watch this video:

About you

Here's what Pfizer is looking for in this role:

Must-Have:

• The ability to work well across lines and functions and to develop productive/collaborative relationships
• Good decision-making skills
• Project and time management skills
• A high level of attention to detail
• Good oral and written communication skills
• Analytical problem-solving skills.
• Degree in a life science discipline
• An understanding of local and international regulatory guidelines, ideally coupled with demonstrated competency in basic regulatory affairs

Nice-to-Have:

• Master's degree
• Relevant pharmaceutical experience
• Strategic thinking with good project management skills

How to apply

To apply for this role, simply click the "Apply on employer site" button on this page to submit your application directly to Pfizer.