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