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   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 (CRLs))  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.

• Plays a supporting role in any appropriate activities in order to influence the regulatory environment through Agency contacts and Trade Associations as appropriate.

Qualifications:

• Bachelor degree in a science subject together with appropriate pharmaceutical  industry experience gained within a global regulatory affairs function.

• Strong proven experience

• 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 problem solving skills

• Strong  written and verbal communication skills

• Ability to work well with appropriate level of independence and appropriate level of supervision

  
Work Location Assignment: Hybrid

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.

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. Your journey with Pfizer starts here!

Regulatory Affairs