Job Description: Europe Regulatory Strategist

• Represent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated late-stage oncology portfolio.
• Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST).
• Lead and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the company goals.
• Accountable for managing the lifecycle of assigned products.
• Accountable for timely submissions and approvals.
• Accountable for ensuring optimal regulatory interactions with Health Authorities, in relation to the designated early-stage oncology portfolio.

Job responsibilities

• Accountable for ensuring contribution to Global Regulatory Strategies and implementation plans for assigned oncology portfolio.
• Ensures regulatory contributions, achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating filing activities.
• Responsible for providing strategic input into EU clinical trial submissions, including protocol and IB review and RFI management.
• Accountable for managing the product lifecycle of assigned products which includes:
  • Preparing and reviewing documentation and supporting materials to be submitted to the EMA including variations and renewal applications with minimal supervision.
  • Maintaining the product information and associated artworks, and working closely with the supply teams to optimise any changes
  • Prepare applications for marketing authorisations in new markets (for existing and new products)
  • Works cross functionally with teams including labelling, CMC and submission management.
  • Works with external regulatory partners.
  • Communicates with and own relationships with health authorities.
• Ensures business compliance and implementation of and adherence to Regulatory standards.
• Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts in the assigned region.

Qualification skills

• Scientific Degree. A higher degree may be an advantage but is not essential.
• Proven experience in managing national and/or regional regulatory process and registration aspects of the drug development process particularly clinical trials experience at least in one country.
• Experience preparing and submitting CTAs and MAA’s.
• Experience of managing an MA post authorisation.
• Previous experience as a national and/or regional regulatory liaison for a product in different stages of its life cycle is highly desirable.
• Experience in communicating with a major EU regulatory agency
• Knowledge of drug development practice rules, regulations and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.
• Working with and influencing regulators and facilitating approval of submissions.
• Ability to communicate complex information and analyses to a variety of stakeholders in both verbal and written format.
• Is effective in a variety of formal presentation settings; one-on-one, small and large groups, with peers, direct reports and senior management.

  
Work Location Assignment: Walton Oaks  or Sandwich (UK), or Milan (Italy) – flexible working arrangements possible.

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

#LI-PFE