Job Description

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.

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 for moderately complex cases
• 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
• Responsible for making updates in PDM Market Views for all the CMC events upon receipt of notification of Submission and Approval evidence
• Contributes to the deliverables of the complex cases with the guidance of Team Lead / Designee
• Applies technical knowledge and key concepts in PDM 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
• 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 to address 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.
• Suggests new ideas to the internal processes and methodologies to make the work easier for the colleagues
• Makes informed decisions while handling moderately complex notifications based on regulatory experience and propses alternatives, guided by policies in non-standard situations
• Works independently
• Receives instruction primarily on unusual or complex problems.
• Takes responsibility for a portion of the Work Team\'s milestones/deliverables as needed
• Support periodic and ad-hoc system reports to estimate metrics
• Assist in ensuring internal regulatory processes and procedures are well documented
• Assist in remediation activities

QUALIFICATIONS / SKILLS

Technical Skills -

• Knowledge and / or experience in Regulatory / Quality /Compliance any other relevant functions within Pharmaceutical Industry
• Prior Regulatory experience in any of the market
• 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 \xe2\x80\x93 An assertive, take-charge, results oriented, positive \xe2\x80\x9ccan do\xe2\x80\x9d attitude, and a sense of urgency doing things done.

• Preferred Qualification \xe2\x80\x93 Master\xe2\x80\x99s / Bachelor\xe2\x80\x99s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
• Preferred Year Of Experience - 8 to 12 years of experience in a quality or compliance role within the pharmaceutical industry 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.

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

#LI-PFE

Pfizer