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Regulatory Associate

1 month ago

Sydney, Australia Pfizer Full time

Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

Bring new medicines to Australian / New Zealand patients, with best labelling to meet their needs, and contribute to accelerated access. Ensure continuity of supply through effective life-cycle maintenance activities.

Provide advice on regulatory strategy to optimise outcomes for the business and patients and influence regulatory policy by maximising relationships with regulatory authorities and pivotal industry bodies.

Be a valued partner by providing regulatory and operational knowledge and expertise to support the business in meeting its objectives.

How You Will Achieve It- For assigned products, in collaboration with Manager as needed:

- Ensure NMEs and line extensions 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
- Work with Regulatory Affairs Manager or more senior colleagues (as assigned by Manager) to develop acceptable regulatory strategies
- Agree on regulatory advice to Pfizer Australia and Worldwide Development partners to assist with good business decision making
- 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**:
Essential
- Bachelor of Science (Life science, Pharmacy) or equivalent.
- Some understanding of local and international regulatory and clinical trial guidelines.
- Proficient computer skills e.g. MS Office, MS Outlook, Internet, database use.

Preferred
- Registered Pharmacist

Work Location Assignment: Flexible

At Pfizer we care about our colleagues’ wellbeing and offer a range of great benefits for them, including:
- Paid parental leave- Access to Health & Wellness apps- Career Growth Experiences program- Recognition & rewards program- Paid volunteer days- Life Insurance Benefits- Pfizer Learning Academy access to top content providers- Access to flu vaccines & skin checks- Options to purchase additional leave- Salary packaging & novated lease options

Regulatory Affairs

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