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.

How You Will Achieve It

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Provide input to the relevant stakeholders for the development of products in-line with business objectives, ensuring strategies are adequately reflected in relevant country plans {e.g., business development or manufacturing supply) & alignment is achieved between regulatory activities and relevant country business/commercial plans.
• Support Regulatory Affairs group development and maintain internal regulatory databases, tracking and document management systems.
• Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Pfizer policies, procedures, and practices.
• Review technical supportive information for submission to support change.
• Ensure compliance and consistency of product labels with local requirements.
• Represent the regulatory team at cross-functional team meetings, where required.
• Escalate any issues or concerns within the functional line and/or relevant leadership for adjudication.
• Ensure assigned projects of manufacturing/packaging site are approved on agreed timeline and closely communicate with site/Logistics to ensure smooth of supply.
• Oversee and manage the completion of clinical trial applications.
• Supports Query and commitment management in collaboration relevant stakeholders.
• Maintain licenses in compliance with local regulations by ensuring that corporate regulatory processes, Standard Operating Procedures (SOPs) and systems are in place, and that staff are trained in these systems and procedures.

Qualifications

Must-Have

• Bachelor's Degree
• 3+ years of demonstrated experience in regulatory affairs or in a regulated industry
• Proven ability to manage complex regulatory issues and consistently deliver to time and quality standards
• In-depth knowledge of the current health regulatory framework for drug regulatory procedures
• Problem solving skills, strong detail, quality and compliance orientation
• Understanding of Combination Products Regulatory Landscape of US FDA, EMA, TGA and RoW
• Understanding of the Part 4 guidance of US CFR for Combination Products
• Working knowledge of PAC of BLA, NDA and ANDA
• Good verbal and written communication skills and fluent in English
• Proficient computer skills, e.g. MS Office, MS Outlook, Internet, database use

Nice-to-Have

• Master's degree
• Relevant pharmaceutical experience
• Strategic thinking with good project management skills
• Exposure to IVDR and SaMD

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

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