This is a Senior QA Regulatory Associate role with Pfizer based in Mulgrave, VIC, AU Pfizer Role Seniority - senior More about the Senior QA Regulatory Associate role at Pfizer 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 Before we jump into the responsibilities of the role. No matter what you come in knowing, you’ll be learning new things all the time and the Pfizer team will be there to support your growth. Please consider applying even if you don't meet 100% of what’s outlined Key Responsibilities ⏰ Contributing to project completion Supporting global regulatory submissions Collaborating with cross-functional teams Key Strengths Regulatory strategy development Project management ✅ Regulatory compliance Pharmaceutical industry experience Analytical skills Proficiency in regulatory information management systems Why Pfizer is partnering with Hatch on this role. Hatch exists to level the playing field for people as they discover a career that’s right for them. So when you apply you have the chance to show more than just your resume. A Final Note: This is a role with Pfizer not with Hatch.
