Senior QA Regulatory Associate

Use Your Power for Purpose
At Pfizer, we are committed to bringing medicines to the world with speed, without compromising on excellence and integrity. Navigating the ever-changing regulatory environment requires forward thinking and meticulous attention to detail. Adhering to both local and global regulations is crucial. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer's innovative medicines and vaccines. By maintaining our high standards and ethical practices, we ensure that patients receive the best possible care. Join us in our mission to make a meaningful impact on global health.

What You Will Achieve
As a Senior Associate in Regulatory Chemistry, Manufacturing, and Control Strategy at Pfizer, you will play a critical role in developing and implementing regulatory strategies for both small and large molecule pharmaceuticals. Your expertise will be essential in preparing regulatory submissions and liaising with health authorities to ensure compliance with global requirements.

• Contribute to project completion and manage time to meet targets.
• Support assembly of Chemistry, Manufacturing and Control (CMC) information for global regulatory submissions.
• Actively contribute to cross-functional initiatives to mitigate risks.
• Ensure compliance with submission standards, procedures, and policies.
• Prepare and finalize Global Regulatory Strategy Documents and Clinical Data Request (CTD) sections for submissions.
• Maintain core dossiers and coordinate responses to deficiency letters.
• Review and apply regulatory guidelines for renewals.
• Recommend solutions and escalate issues with significant impact.
• Independently manage projects and execute strategies with minimal oversight.
• Collaborate with cross-functional teams to support regulatory strategies.

Here Is What You Need (Minimum Requirements)

• A BA /BS with 2+ years of experience
• Demonstrated commitment to scientific and regulatory integrity and quality compliance
• Sound understanding of regulatory processes and requirements for defined market(s) and able to interpret and apply to projects
• Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems and willingness to support others in system use
• Demonstrated integrity in decision making on regulatory issues in line with company values
• Ability to contribute to effective teams and implement change and make decisions to resolve problems in standard situations
• Competent working knowledge of computer-based systems, such as Microsoft Office, controlled documentation systems

Bonus Points If You Have (Preferred Requirements)

• Pharmaceutical industry experience
• Experience in regulatory CMC strategy for both small and large molecule pharmaceuticals
• Proficiency in regulatory information management systems.
• Strong analytical and problem-solving skills
• Project management experience

Work Location Assignment: On Premise

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.

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.

Regulatory Affairs