Regional Regulatory Strategist (Senior Manager) Rare Disease

Recruiter
Pfizer
Location
Cambridge
Salary
Competitive
Posted
14 May 2022
Closes
11 Jun 2022
Contract Type
Permanent
Hours
Full Time

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.

Qualifications

  • 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.

Nice-to-Have

  • 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.