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Global Regulatory Strategist - EU, Hospital BU Brands

Employer
Pfizer
Location
Sandwich
Salary
Negotiable
Closing date
22 Jul 2020

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Job Details

Role Summary

The purpose of this position is to:

  • Create and deliver strategic regulatory guidance for assigned projects/products. Strategies should be in alignment with global/regional positions, commercial goals, and key stakeholders/partner lines
  • Develop and implement Regulatory Strategies for assigned projects/products including assurance that project prioritization, submission strategies, labeling, approvals, post-marketing lifecycle management activities, etc., are in place and delivered in accordance with time, cost and quality expectations for all assigned projects.
  • Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.
  • Direct and/or indirect liaison with regulatory authorities to facilitate the prompt review and approval of applications, supplements/variations, and commitment closures.
  • Lead and/or participates in Regulatory Teams for assigned projects/products.
  • Develop and implements regulatory strategies to support/maintain registrations. Maintains product licenses across all product platforms.
  • Understand regulatory environment and communicates priorities to global stakeholders.
  • Deliver project /product strategy incl. label, risk assessment, and PRS for assigned projects/products.

 

Responsibilities

The major duties and responsibilities include

  • Accountable for ensuring or contributing to Global/Regional Regulatory Strategies and implementation plans (including core labels, risk registers) developed for assigned project/s.
  • Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, and minimize resource demands while maximizing overall project delivery time and probability of success and facilitating post filing activities.
  • Partners with project teams and other customer groups (e.g., Country Regulatory Managers, Brand Teams, PGS, etc.) to ensure required regulatory contributions (e.g. briefing documents, line plans, IND, NDA) 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 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 and CMC Product managers within, and across, sites to ensure consistent and appropriate processes, systems, working practices, shared learning's and quality standards.

 

Qualifications

  • Regulatory Knowledge: Knowledge of the regulatory environment and how this impacts regulatory strategy and implementation. Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting MAAs, line extensions, NDAs, INDs. Working with and influencing, opinion leaders, external organizations facilitating approval of submissions.
  • Therapeutic Area Knowledge: Has working knowledge of the therapeutic area, through prior regulatory experience; direct product development and/or academic training
  • Communication skills: Communicates effectively using a variety of mediums appropriate to the setting.
  • Negotiation skills: Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations
  • B.S. Scientific Degree required. An advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) may be an advantage but is not essential.

 

Closing statement

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!

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.

Closing date for applications: July 22nd.

All applicants must have the relevant authorisation to live and work in the EU.

Company

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. 

In the UK, we have around 2,400 colleagues across four locations, working within our commercial business, research and development (R&D), manufacturing and distribution operations.

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