Associate I – Regulatory Conformance

4 weeks ago


Chennai, India Pfizer Full time

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 an associate, your focus on the job will contribute in achieving your team’s 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.

Committed to quality and excellence in compliance and conformanceWith 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 / MarketsContributes 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 policiesSupport for updates in system for License withdrawalsOperate in line with internal SOPs and policiesAdhere to standard turnaround timelinesEscalate any potential compliance issues to managementSupport periodic and ad-hoc system reports to estimate metricsContribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer valuesAssist in ensuring internal regulatory processes and procedures are well documentedAssist in remediation activitiesSupport the teams in ADHOC activitiesShares the learning time to time with the team colleagues

Technical Skills -

Theorotical Knowledge on Regulatory Affairs / ComplianceExperienced in Regulatory / Quality Assurance/ Production or any other functions in Pharmaceutical or related industriesDiligence and attention to detailGood communication skillsUnderstanding stakeholder needs

Behavioral /Any other Skills – An assertive, results oriented, positive “can do” attitude, and Time management skills. Preferred Qualification – Master’s / Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.  Preferred Year Of Experience - 2 to 4 years of experience

Type of Experience – Any relevant experience in Pharmaceutical or relevant industry. Experience in Regulatory or Quality or Compliance roles is preferable.


Work Location Assignment: On Premise

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
  • Associate I

    2 months ago


    Chennai, India Pfizer Full time

    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...

  • Associate I

    7 days ago


    Chennai, India Pfizer Full time

    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...

  • Associate I

    2 months ago


    chennai, India Pfizer Full time

    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...

  • Associate I

    2 months ago


    Chennai, India Pfizer Full time

    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...

  • Associate I

    2 months ago


    Chennai, Tamil Nadu, India Pfizer Full time

    **Job Description**: 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 RA status in corporate change and dossier management system for the allocated Regions / Markets - Contributes...


  • chennai, India Pfizer Full time

    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...

  • Associate Ii

    2 months ago


    Chennai, Tamil Nadu, India Pfizer Full time

    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 RA status in corporate change and dossier management system for the allocated Regions / Markets - Contributes independently and manages...

  • Associate I

    2 months ago


    Chennai, India Pfizer Full time

    Reviews proposed changes for completeness and accuracy and development of initial global regulatory strategy while considering registered content and seeks endorsement by the CMC GRS. - Authors and/or compiles Regulatory Strategy Documents (RSD) where needed, as well as CMC submission packages globally, i.e.Module 1, Module 2.3, M3.2S/P/R under guidance from...

  • Pls Associate-i, Usc

    1 month ago


    Chennai, India Pfizer Full time

    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...


  • Chennai, India NatWest Group Full time

    Our people work differently depending on their jobs and needs. From hybrid working to flexible hours, we have plenty of options that help our people to thrive. This role is based in India and as such all normal working days must be carried out in India. Join us as a Regulatory Control Associate - This is a great opportunity to join our business and play a...

  • Associate I

    2 months ago


    Chennai, India Pfizer Full time

    The LOM, Associate I will provide operational support for project tasks including: - Generate necessary renditions in GDMS (e.g., clean and marked PDF, clean and marked MS Word) and bookmark renditions as appropriate. - Facilitate workflow through corporate document repository, e.g., GDMS. - Finalize documents post QC (including update of GDMS document...

  • Associate-i, Plmds

    2 months ago


    Chennai, India Pfizer Full time

    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...

  • Associate-i, Plmds

    1 month ago


    Chennai, India Pfizer Full time

    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...

  • Associate-i, Plmds

    1 week ago


    Chennai, India Pfizer Full time

    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...

  • Associate-i, Plmds

    5 days ago


    Chennai, India Pfizer Full time

    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...


  • Chennai, Tamil Nadu, India BNY Mellon Full time

    Associate, Regulatory Analysis and Reporting II Bring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the...

  • Associate I

    2 months ago


    Chennai, India Pfizer Full time

    Manages day-to-day regulatory activities associated with assigned LEC variations within agreed upon timelines. - Evaluate change controls for completeness, accuracy and required supporting documents. Initiate change controls when needed. - Performs Market Impact Assessment (MIA) for the specific entity name change. - Runs the Regulatory Requirement Manager...


  • Chennai, India BNY Mellon Full time

    Associate, Regulatory Analysis and Reporting IIBring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the...


  • Chennai, India BNY Mellon Full time

    Associate, Regulatory Analysis and Reporting IIBring your ideas. Make history. BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the...


  • Chennai, India INTERMED Full time

    Explain regulations, policies, or procedures - Maintain data in information systems or databases - Ensure compliance with regulations - Advise others on regulatory and compliance matters - Evaluate applicable laws and regulations to determine impact on company activities - Provide technical review of data or reports - Coordinate regulatory documentation...