Regional Regulatory Hub Strategist (Suba)

**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 integral 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

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. This is a multifaceted role that will offer you a number of opportunities to enhance your skills. Your focus and ability to meet the team’s targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

**How You Will Achieve It**:

- Accountable for creating drug product submissions for BoH acceptability in terms of content, according to local regulations and requirements. This includes HA query responses.
- Ensure dossiers (Example: electronic, paper copy, and HA portal) are produced and dispatched to markets according to their defined filing plan, and are submission ready.
- Ensure the processes transparency and excellence in execution of regulatory strategies.
- Maintain the accuracy of the data in the systems and databases per internal SOPs and policies.
- Work in collaboration across the organization with stakeholders (such as Product Strategist, Commercial, Operations) to deliver efficiencies in regulatory submissions and processes.

**Qualifications**:**Must-Have**:

- Bachelor's Degree
- MSc, MBA or PhD may be an advantage
- 3+ years of experience
- Demonstrated success in effectively managing and optimizing standards in regulatory information systems
- In-depth knowledge of the current health regulatory framework for drug regulatory procedures
- Scientific knowledge and strong analytical skills to make sound quality assessments of project strategy and documentation
- Quality focus and ability to work with accuracy and attention to detail
- Good communication skills
- Team player
- Change agile

**Nice-to-Have**:

- Master's degree
- Relevant pharmaceutical experience
- Experience with Biotechnological products

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

Regulatory Affairs

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