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23-25 Week Maternity Leave (Fully paid for birth parents)
Family building benefits include $35,000 fertility services + $25,000 adoption and surrogacy services
Pfizer is a founding member of Healthcare Businesswomen's Association Gender Parity Collaborative
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
Regional (US, EU, and/or EM) Regulatory Strategist providing regulatory contributions aligned to meet business needs in agreement with key stakeholders.
Lead regional regulatory milestones, deliverables, and process, strategically accelerating assigned projects in the innovative end-to-end Rare Disease portfolio (inclusive of lifecycle support), with timely submissions and approvals and commercially attractive labelling.
Partner with the Global Regulatory Sub‑Team (GRST) to implement an aligned regulatory strategy for assigned project / products.
Act as direct liaison with Health authorities in the designated region to facilitate the prompt review and approval of applications.
Enable early and late clinical development activities by providing regulatory advice.
As appropriate develop and implement regulatory strategies to support initial registrations. Maintains product licenses across all assigned products.
Strong knowledge of the regulatory environment and communicates priorities to global stakeholders.
How You Will Achieve It
Responsible for providing strategic regulatory expertise and leadership on assigned projects in the Rare Disease portfolio at all stages of development, including product lifecycle.
Develop, maintain, and implement Regulatory Strategies (including core labels, risk registers) for assigned project(s) across the product lifecycle.
Ensures regulatory contributions achieve the objectives of the strategy, achieve agreed standards, and maximize probability of success.
Leads and partners with project teams and other customer groups (e.g. RU, BU, and Commercial teams) to ensure required regulatory contributions (CTA/IND, MAA/NDA/BLA, supplements/variations, license renewals etc) meet business needs and are provided to the project teams, to agreed time, cost and quality standards.
Ensures regulatory plans are monitored, progress/variance communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated.
Ensures an aligned regulatory position related to milestones, deliverables, and process is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the business are championed and communicated.
Works closely with other Regulatory Strategists within and across sites to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards.
Implements systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines.
Ensures business compliance and implementation of and adherence to Regulatory standards.
Develops and maintains constructive working relationship with Health Authority contacts as appropriate.
Scientific Degree; an advanced degree (MSc or PhD) may be an advantage as strong scientific understanding to enable regulatory product development is expected.
Direct experience with innovative regulatory strategies (i.e., in the US, EU, and/or EM) enabling full development programs including leading submissions and achieving approvals under expedited pathways.
Direct experience in communicating with major regulatory agency(ies) (ie FDA, EMA, Japan), as well as participating in/leading such interactions for meetings to advance programs collaboratively.
Demonstrable experience to influence and deliver succinct messages in a complex matrix environment.
Strong strategic thinking, team working, problem solving, communication and interpersonal skills.
Knowledge of national/regional and global regulatory legislation and guidelines.
Basic knowledge in drug development science.
Prior experience with gene therapy development is desirable or has demonstrated skills with novel therapies, biologics, or new modalities
Ability to operate in both strategic and tactical settings.
Ability to manage multiple projects, create and manage project timelines.
The closing deadline for applications is May 29th.
All applicants must have the relevant authorisation to live and work in the UK / EU as applicable.
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.
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.
Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place. Every day, our colleagues work in developed and emerging markets to ...