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)