Regional Regulatory Hub Strategist

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 global 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

You will represent Pfizer as an approval liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the regulatory liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments and periodic experience reports.

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.

**Responsibilities**:

- Accountable for coordinating the submissions for post appoval, NCE and biologics Drug Products by countries acceptability in terms of content, according to local regulations and requirements. This includes HA query management.
- Understand local regulations and trends, as communicated by the PCO.
- Liaise with CMC, Submissions Management, Cluster/Market, and any other key stakeholders to ensure BoH requirements are met.
- Create submissions as per assigned responsibility, ensuring BoH requirements are met.
- Author local submission documents in relevant databases, as applicable.
- Execute regulatory strategy (including timelines) in alignment with the agreed upon strategy from key stakeholders (i.e., Global Regulatory Team, PGS, Markets, Clusters, Labeling team, Submissions Management, CMC) to ensure a submission ready dossier.
- Liaise with the manufacturing sites for obtaining supporting documents as needed
- Utilize a submission planning and forecasting tool to update timelines when necessary.
- Review submission packages against local BoH requirements for consistency and completeness.
- Update the appropriate regulatory requirements systems and database in a timely manner when changes occur in market regulations.
- Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention, as needed
- Complete departmental training in a timely manner to address corporate and regulatory compliance.
- Drive improved efficiencies across the region through achieving consistency in submission strategies and its execution. Make suggestions and recommendations that contribute to improvements in the Hub.
- Maintain an active partnership with counterparts across the Hubs

**Qualifications**:
Must-Have
- Bachelor’s degree or equivalent i.e., degree in Chemistry, Pharmacy, or a related life science
- MSc, MBA or PhD may be an advantage
- Experience in regulatory affairs, preferably in human medicines - minimum 3 years
- Demonstrate regulatory experience with a pharmaceutical company.
- Proven ability to support complex regulatory issues and consistently deliver to time, cost and quality standards.
- Demonstrate experience of effective delivery in a complex matrix environment.
- Bilingual (English/Spanish)

Work Location Assignment: Flexible

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

Regulatory Affairs