Regional Regulatory Hub Strategist

What Pfizer Can Offer You

Recognised as one of the top innovative Pharma companies, we realize that delivering on our purpose means not just attracting the best and brightest talent but also ensuring our colleagues can thrive in an environment and culture where we champion diversity and inclusion. Equity is a core value at Pfizer, where we believe every person deserves to be seen, heard, and cared for, and we work to further this goal by bringing together people with different backgrounds, perspectives and experiences. Our colleague resource groups have contributed to a more diverse and inclusive workplace, providing representation and meaningful connections, where our people feel empowered to bring their whole selves to work and fosters an environment where our people can thrive and grow.

Why Patients Need You

We're looking to bring our breakthrough medicines to the world faster maintaining the highest standards on compliance and integrity. Adhering to local and regional regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand, accelerate, and maintain patient access to Pfizer breakthrough medicines and vaccines.

What You Will Achieve

Joining our purpose centric and diverse team you will succeed by embracing our corporate culture and living our values each day. You are highly engaged and committed, leveraging your expertise and skills ensuring patient access to breakthroughs via proactively maintaining our licences. Your ability to identify, evaluate and mitigate regulatory risks will ensure continuous patient access throughout the product lifecycle.

Your proactive engagement will establish you as the partner of choice for our global and regional teams.

How You Will Achieve It
- Accountable for supporting regulatory CMC submissions across a defined set of EuCANZ markets with a focus on lifecycle maintenance.
- Ensure transparency and excellence in evaluation, definition and execution of regulatory strategies and associated timelines for registrations
- Ensure country acceptability in terms of content, according to local regulations and requirements for assigned markets including HA query management
- To proactively build local relationships and ensure communication/clarity of regulatory timelines and strategy.
- Oversight of Portfolio Planning activities for assigned markets ensuring submission execution as per defined filing plan.
- Advanced understanding of regulatory processes and requirements for defined market(s) and able to translate into product strategies and business processes.
- Contributes to the development of regulatory strategy in support of the broader product portfolio or specific manufacturing or compliance initiatives.
- Proactively drives corporate culture and innovation
- Demonstrates initiative and proactively drives activities across regional hub and partner lines.
- Represents the regional hub and/or EuCANZ on regional or global initiatives

Qualifications

Must-Have
- Bachelor's Degree (BSc) or equivalent and proven experience
- Relevant pharmaceutical or regulatory experience and business knowledge.
- Good knowledge of EU and/or emerging markets Europe Regulatory environment, procedures, and requirements.
- Ability to manage regulatory issues and consistently deliver to time, cost and quality standards
- Strong verbal and written communication skills.

Nice-to-Have
- Demonstrated experience in regulatory affairs or compliance
- Experience working cross-functionally on broad and strategic initiatives

Work Location Assignment: Flexible
Purpose
-Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
-Digital Transformation Strategy
-One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
-Flexibility
-We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation
-Equal Employment Opportunity
-We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Regulatory Affairs

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