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 expand and accelerate patient access to Pfizer medicines and vaccines. 

What You Will Achieve 

You will represent Pfizer as an Senior Manager in the regulatory Sciences team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you may be the Regulatory Strategist on the project team throughout a product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. 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 Manager, you will be setting the objectives for multiple projects in your Department. Your managerial and technical skills will help in guiding the people in your Department. Your understanding of the external marketplace and customer requirements will facilitate in instituting knowledge sharing practices in your team and outside. You shall be relied on to manage operational activities that support the goals of the Department, business and division and set direction for its success. 

Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare. 

How You Will Achieve It 

• Set objectives for and manage multiple projects within a Department/division. 

• Develop innovative, advanced new concepts that improve processes or products across own and related disciplines. 

• Develop and implement Regulatory Strategies for assigned projects/products including assurance that project prioritization, submission strategies, labeling, approvals,  
  post-marketing lifecycle management activities, are in place and delivered in accordance with time, cost and quality expectations for all assigned projects. 

• Develop and enhance the capabilities and capacities of the Regulatory Sciences teams through the identification and implementation of training and development needs.  

• Maintain licenses  in compliance with local regulations of the countries by ensuring that corporate regulatory processes, Standard Operating Procedures (SOPs) and systems are in place, also ensure team is properly trained in these systems and procedures.  

• Maintain and update the Local Product Document (labeling) in accordance with relevant regulations and  SOPs. 

• Set up new product registration plan, prepare the regulatory submissions for registration of new products, variations  and renewals to marketed products and clinical trial applications.

• Develop and enhance relationships with key external agencies, strong partnerships with in-country or cluster markets that give support to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.

• Analyze resource requirement and forecast for the assigned projects/products across departments and works in collaboration and cooperation with Portfolio Leads to ensure that adequate resources are assigned to assigned projects.

• ​Mentor, develop and coach Regulatory Strategists for projects within the relevant portfolio(s) including all aspects of the performance management process as appropriate. 

Qualifications 

Must-Have 

• Bachelor's Degree (BA/BS) and 9+ years of experience.  

• Knowledge of the Regional and Global regulatory environment.  

• Knowledge of drug development practice, rules, regulations and guidelines. 

• Understand Business and Financial Environment. 

• People Management experience. 

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Nice-to-Have 

• Master's degree (MA/MBA/MS) and 7+ years of experience. 

• Doctorate (PhD/PharmD/JD) with 4+ years of experience. 

• Thinks strategically with good project management skills. 

• Ability to lead and/or work with diverse cross functional teams. 

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.