# Regulatory Affairs

**Company**: Pfizer
**Location**: Walton Oaks, United Kingdom
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/United-Kingdom---Walton-Oaks/Europe-Regulatory-Strategist_4966306-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_082800fc-aad

## Description

At Pfizer, you will play a pivotal role in broadening and hastening patient access to Pfizer's medicines and vaccines.

**What You Will Achieve**

In this role, you will:

- Represent a particular region for regulatory sciences (US, EU or EM).

- Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST).

- Lead and implement regional regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals.

- Be accountable for timely submissions and approvals with commercially attractive labelling in the designated region.

- Be accountable for ensuring optimal regulatory interactions with Health Authorities, in relation to the assigned project(s) within the designated region.

- Ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating post-filing activities.

- Partner with project teams and other customer groups to ensure required regulatory contributions meet business needs and are provided to the project teams, to agreed time and quality standards.

- Ensure regulatory plans are monitored, progress/variance communicated to Global Regulatory Lead and Senior Management, and any risks mitigated.

- Ensure an aligned regional regulatory position is reached and communicated for all key issues for assigned project/s.

- Engage in activities to influence the regional regulatory environment.

- Ensure business compliance and implementation of and adherence to Regulatory standards.

- Develop and maintain constructive working relationships with Health Authority contacts in the assigned region.

**Here Is What You Need**

- 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.

- Previous experience as a national and/or regional regulatory liaison for at least one product in different therapeutic areas and in different stages of the product life cycle is highly desirable.

- Experience in communicating with FDA or major EU regulatory agency(-ies).

- Knowledge of drug development practice rules, regulations and guidelines.

- Proven ability in developing and implementing regulatory strategy.

- Communication skills.

- Presentation skills.

- Negotiation skills.

**Bonus Points If You Have**

- Familiarity with electronic submission processes and regulatory information management systems.

- Ability to work effectively in a fast-paced, dynamic environment.

- Strong interpersonal skills and the ability to work collaboratively with cross-functional teams.

- Excellent organizational and time management skills.

- Ability to adapt to changing priorities and manage multiple tasks simultaneously.

- Strong analytical skills and the ability to interpret complex regulatory guidelines and requirements.

- Experience using common AI tools.

Work Location Assignment: Hybrid (some office presence is required)

## Skills

### Required
- regulatory affairs
- drug development
- regulatory strategy
- communication skills
- presentation skills
- negotiation skills

### Nice to have
- electronic submission processes
- regulatory information management systems
- AI tools
- interpersonal skills
- analytical skills

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Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/United-Kingdom---Walton-Oaks/Europe-Regulatory-Strategist_4966306-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)