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 maintain patient access to Pfizer medicines.

What You Will Achieve

You will represent Pfizer as an approval liaison in the regulatory affairs team. You will play the critical role of providing strategic Chemistry, Manufacturing, and Controls (CMC) direction to teams while interacting with local and regional regulatory colleagues and with internal manufacturing site stakeholders. Due to your expertise, you will be the regulatory liaison throughout the product lifecycle as CMC Strategist. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments and periodic experience reports.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team.  Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your dedication and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Assist in developing and implementing regulatory strategy that aligns with business needs, including growth projects and activities relating to maintaining registrations, product defense and regulatory compliance.
• Execute, through use of standards and tools, designated operational tasks or through the applicable Pfizer country office, conforming to regulatory submission milestones and applicable regulatory obligations.
• Represent the team in limited duration teams, process improvements, and key project meetings.
• Responsible for life-cycle management of assigned products as CMC Strategist.

Qualifications

Must-Have

• Bachelor's Degree
• 3+ years of experience
• Industry experience in Regulatory Affairs
• Knowledge of the regulatory environment and how this impacts regulatory strategy development and implementation
• Dossier preparation for global submissions
• Technical expertise
• Proven ability to consistently deliver to time and quality standards
• Strong problem-solving skills and team orientation, and positive outlook
• Excellent written and verbal communication skills
• Good knowledge of Windows and Microsoft Office

Nice-to-Have

• Master's degree
• Relevant pharmaceutical experience
• Awareness of and ideally experience in successfully responding to CMC queries from the Health Authorities
• Familiarity with pharmaceutical organizational structures, systems, and culture

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

*Benefits listed may vary depending on your position and location and may be subject to change.

Work Location Assignment: Flexible

Pfizer Australia and New Zealand’s diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.

If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.