Job Description

Why Patients Need YouWe'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 AchieveYou 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 an associate, your focus on the job will contribute in achieving your teams tasks and goals. This is a multifaceted role that will offer you a number of opportunities to enhance your skills. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.Job Summary

• Committed to quality in compliance and conformance
• Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets
• Manages the day to day work by self with periodic supervision by the Lead/Designee

Job Responsibilities

• Committed to quality and excellence in compliance and conformance
• With the reasonable understanding of regional regulations, would perform the evaluation of the notifications assigned.
• Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets
• Contributes independently and manages own time to meet the timelines.
• Work in collaboration with GRA colleagues to ensure the gaps are identified and escalated on time.
• Independently Perform accurate updates in system for most of the cases and consult with TL/Designee for clarification of any discrepancies in complex cases, before updating the system.
• Makes informed decisions on straight cases within guidelines and policies
• Support for updates in system for License withdrawals
• Operate in line with internal SOPs and policies
• Adhere to standard turnaround timelines
• Escalate any potential compliance issues to management
• Support periodic and ad-hoc system reports to estimate metrics
• Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values
• Assist in ensuring internal regulatory processes and procedures are well documented
• Assist in remediation activities
• Support the teams in ADHOC activities
• Shares the learning time to time with the team colleagues

QUALIFICATIONS / SKILLSTechnical Skills -

• Theorotical Knowledge on Regulatory Affairs / Compliance
• Experienced in Regulatory / Quality Assurance/ Production or any other functions in Pharmaceutical or related industries
• Diligence and attention to detail
• Good communication skills
• Understanding stakeholder needs

QUALIFICATIONS / SKILLSStandards, Processes and Policies - General standards, processes and policies of Pfizer Behavioural/Any other Skills - An assertive, results oriented, positive can do attitude, and Time management skills. Preferred Qualification - Masters / Bachelors degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences. Preferred Year Of Experience - 2 to 4 years of experienceType of Experience - Any relevant experience in Pharmaceutical or relevant industry. Experience in Regulatory or Quality or Compliance roles is preferrable.
Work Location Assignment: FlexiblePfizer 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