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11

February

Regulatory Affairs Associate

Pfizer - Sydney, NSW

Health, Medical & Pharmaceutical
Source: uWorkin

JOB DESCRIPTION

As a result of a vacancy, there is the opportunity to 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. 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.

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.

For the successful candidate, the job responsibilities will include:

As opportunities arise, work with Regulatory Affairs Manager or more senior colleagues (as assigned by Manager) to develop acceptable regulatory strategies to 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

Ensure maintenance of in line product by carrying out all product lifecycle regulatory activities

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.

To be considered for this opportunity you will have:

Good understanding of regulatory affairs in Australia and New Zealand, with demonstrable experience in similar roles.

The ability to work well cross functionally and to develop productive/collaborative relationships

A high level of attention to detail

Excellent oral and written communication skills

Analytical problem-solving skills

Good decision-making skills

Project and time management skills

By joining Pfizer, you will partner with colleagues of diverse backgrounds and abilities, people who contribute to all aspects of what we do—from drug development to marketing, technology to sales, and so much more.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

#LI-PFE

Pfizer

Sydney, NSW

Health, Medical & Pharmaceutical




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