Job Description

Use Your Power for Purpose

We are committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your unwavering dedication and specialized knowledge 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:

• Be responsible for providing operational regulatory support to the International country and/or cluster Regulatory teams.

• Work across portfolio phases from initial registration applications, lifecycle management through to product withdrawal to support numerous regulatory activities that include but are not limited to;

- M1 dossier components (local document authoring and/or coordination)

- Simple local only HA query responses,

- Provide support for general x-functional activities to country Regulatory teams for tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and coordination of regulatory input for launch planning.

• Partner closely with the Country Regulatory Strategist and Hub Submission/Dossier Managers to enable timely, high-quality submissions and sustained compliance. This includes but is not limited to:

- Identification of regulatory requirements (for the in-scope submission categories defined),

- Authoring, delivery and/or coordination of local, submission-ready documents and

- The quality review/approval of the Dossier provided by Hub Submission/Dossier Managers (for the in-scope submission categories defined).

Here Is What You Need (Minimum Requirements)

• B.Pharm/BA/BS with 2+ years of experience

• Demonstrated experience in regulatory affairs or in a regulated industry

• In-depth knowledge of the current health regulatory framework for drug regulatory procedures

• Strong problem-solving skills, attention to detail, and a quality and compliance orientation

• Excellent verbal and written communication skills, and fluent in English

• Proficient in MS Office Suite

Bonus Points If You Have (Preferred Requirements)

• A Master's degree along with relevant pharmaceutical experience

• 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, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs