Regulatory Affairs Associate

2 days ago

Sydney, Australia Pfizer Full time

Why Patients Need You

This is a great opportunity to become part of a dedicated and successful Regulatory Department and to help us make a meaningful difference to the lives of patients in Australia and New Zealand. Our Team is talented, collaborative, diverse and made up of experienced regulatory professionals who always strive for the best outcomes for patients. The working environment is supportive, and we encourage colleagues to develop their own skills in line with their personal and Departmental goals.

What You Will Achieve

Join a strong, experienced and dynamic Regulatory Affairs Department, as a Regulatory Affairs Associate. Located in Sydney CBD, this is a permanent, full-time position reporting to the Regulatory Affairs Manager/Head of Department.

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

How You Will Achieve It
- Ensure regulatory submission 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 labelling, CMC and artwork
- Ensure maintenance of in line product by carrying out all product lifecycle regulatory activities
- Work with Regulatory Affairs Manager or more senior colleagues (as assigned by 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.

**Qualifications**:
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 couple with demonstrated competency in basic regulatory affairs

Nice-to-Have
- Master's degree
- Relevant pharmaceutical experience
- Strategic thinking with good project management skills

Work Location Assignment: Flexible

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