We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
We have an exciting opportunity for a Regulatory Strategist (Manager) to join our Vaccines Global Regulatory Science team. This is an excellent opportunity to join a growing and dynamic team and be in charge of various projects across different franchises. We are looking for candidates with a dynamic and agile profile with a scientific background and regulatory experience. The candidate should be passionate for vaccines, willing to learn and advance in their career.
Responsibilities
* Reports to the Global Regulatory Lead: Assist in developing and implementing regulatory strategy that aligns with business needs, including growth projects and activities relating to maintaining registrations, product defense and regulatory compliance.
* Contribute to regulatory strategy and operational activities for projects/products (including across different franchises within the Department): preparation and submission of correspondence and applications to regulatory agencies.
* Participate in Regulatory and cross-functional teams for assigned projects/products. With appropriate supervision, direct and/or indirect liaison with Health Authorities (in conjunction with Country Regulatory Leads) to facilitate the prompt review and approval of applications, supplements/variations, and commitment closures.
* Implementing systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring the sharing of information and learnings across the relevant lines.
* Play a supporting role in any appropriate activities in order to influence the regulatory environment through Agency contacts and Trade Associations as appropriate.
* Work Location Assignment: Hybrid.
Qualifications
* Bachelor degree in a science subject together with appropriate pharmaceutical industry experience gained within a global regulatory affairs function.
* Understanding of vaccines and immunology advantageous.
* Knowledge of the regulatory environment and how this impacts regulatory strategy development and implementation and awareness of the functioning of the pharmaceutical industry.
* Ability to manage complex issues with appropriate support, such as global and/or regional regulatory and registration activities involved in the drug development process and/or post-marketing lifecycle management or leveraging regulatory policy issues to support commercial objectives.
* Strong written and verbal communication skills.
* Ability to work well with appropriate level of independence and appropriate level of supervision.
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.
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, attract talent and enable everyone to be their best working self. Let’s start the conversation!
DisAbility Confident: We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers.
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