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 be part of a team that will guide Pfizer by interpreting federal, state and international regulations as they apply to products, processes, practices and procedures. You will find yourself investigating and resolving compliance problems from within Pfizer and outside. You will keep the employees aware and knowledgeable about compliance policies by designing various programs. You will be relied on to conduct audits, compliance reviews and evaluate current policies, procedures and documentation.

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.

JOB SUMMARY

• Committed to quality and excellence in compliance and conformance

• Accountable for maintaining the corporate change and dossier management system (PDM) health authorities per internal SOPs and policies.

• Work in collaboration with regulatory colleagues to ensure compliance and deliver efficiencies in the regulatory submission process.

JOB RESPONSIBILITIES

• Committed to quality and excellence in compliance and conformance
• Accountable for maintaining the corporate change and dossier management system (PDM) regarding the status of regulatory CMC submissions with global health authorities per internal SOPs and policies.
• Contributes to the completion of PDM updates independently
• Manages own time on deliverables  
• Responsible for evaluation of all CMC notifications for accuracy.
• Ensures all the gaps are being addressed in-line with the defined processes and the current regulations
• Contributes to the deliverables of the complex cases with the guidance of Team Lead / Designee
• Applies technical knowledge and key concepts in Conformance updates.
• Exercises own judgment utilizing breadth of knowledge and prior work experience, in agreement with TL/Designee
• Uses the knowledge to provide ideas towards excellence in the Conformance activities
• Provides guidance to colleagues while handling the complex notifications as needed
• Acts as a technical guide for the colleagues for specific regions
• Considered as a technical SME for selected markets / Products
• Performs random QC checks to improve the efficiency of the team
• Supports in ADHOC activities / Withdrawal activities as necessary
• Operate to the highest conformance and quality standards
• Operate in line with internal SOPs and policies
• Adhere to standard turnaround timelines
• Escalate any potential compliance issues to management
• Liaise with regulatory colleagues and ensures timely escalations toaddress the potential issues
• Provide input to continuously improve and streamline the process
• Contribute to local and regional regulatory initiatives by establishing a culture aligned with Pfizer values and which supports compliance.
• Ensures to utilize the internal tracking system efficiently to manage self and contribute to overall metrics management for the team.

QUALIFICATIONS / SKILLS

Technical Skills -

• Knowledge and / or experience in Regulatory / Quality /Compliance any other relevant functions within Pharmaceutical Industry
• Strong quality and compliance orientation
• Knowledge of regulatory practices, rules, regulations and guidelines
• Diligence and attention to detail
• Good communication skills
• Understanding stakeholder needs

Standards, Processes and Policies - General standards, processes and policies of Pfizer/Pharmaceutical Industry

Behavioural/Any other Skills – An assertive, take-charge, results oriented, positive “can do” attitude, and has sense of urgency as appropirate

Preferred Qualification – Master’s / Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences. 

Preferred Year Of Experience - 6 to 9 years

Type of Experience - Demonstrated regulatory or quality or any relevant experience within a Pharmaceutical / Lifesciences Industry. Proven ability to consistently deliver to high quality standards and timelines.

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