Associate I

3 weeks 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 to determine the filing action and impacted sections specific for entity name change and to obtain confirmation from the Regional Regulatory Lead.
- Search Regulatory databases for Common Technical Document components or request them from appropriate market contacts, when not available.
- Familiarity with global guidelines for filing Legal Entity Changes (LEC) and run corresponding reports in the regulatory requirements database.
- Should be familiar with submission grouping practices.
- Request documents from the sites/markets/center functions as needed.
- Request Ancillary documents from Ancillary documents team.
- Communicate with markets if clarification/prioritization is needed.
- Follow up with all responsible disciplines to be able to meet timelines.
- Authoring of the impacted CMC sections i.e. Module 3 under the guidance from the CMC GRL as appropriate and within agreed timelines.
- Responsible for obtaining the approval in Reg-459 form from GRL on the completion of authoring the sections.
- Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc., as appropriate.
- Must be extremely organized as LEC projects can run across multiple products/markets.
- Ensures compliance to Pfizer internal procedures and training SOPs

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 Level I

    1 month ago


    Chennai, India BNP Paribas Full time

    ASSOCIATE LEVEL I (JOB NUMBER: BUS000881) **Direct Responsibilities** Develop & maintain all BCP related documentation Propose functional and technical recovery solutions, to be validated by the management of the entity and/or BCP Committee Ensure that members of staff are adequately trained for BCP. Roll out an awareness program Be an active member of...

  • Associate I

    4 weeks 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...


  • Chennai, India Guidehouse Full time

    Job Family:EBO Accounts Receivable (India), EBO General (India)Travel Required:NoneClearance Required:NoneWhat You Will Do: Plans, monitors, direct and evaluate Associates production. Ensures that schedules are met and communicates with VP, and Associates Operations if situations occur that hinder meeting deadlines.   If system issues or other emergencies...


  • Chennai, India Illumine-i Full time

    The Big PictureThe Electrical Engineer - Utility scale projects will own and drive the end-to-end designs for utility scale solar/BESS projects (20MW+), while also collaborating closely with cross functional teams to ensure on time delivery of high quality, fully compliant and comprehensive project solutions.What you can expect as Electrical Engineer –...


  • Chennai, India Illumine-i Full time

    The Big PictureThe Electrical Engineer - Utility scale projects will own and drive the end-to-end designs for utility scale solar/BESS projects (20MW+), while also collaborating closely with cross functional teams to ensure on time delivery of high quality, fully compliant and comprehensive project solutions.What you can expect as Electrical Engineer –...


  • Chennai, India BNY Mellon Full time

    Vice President, Quality Assurance and Testing I 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...

  • Rapd Associate I

    1 month ago


    Chennai, India Pfizer Full time

    Contribute to the completion of project milestones and organize own work to meet project task deadlines. - Ensure compliance of the team to the submission standards, procedures and policies framed by Global Regulatory Affairs. - Responsible for the preparation and finalization of Global Regulatory Strategy Documents (GRSD), Comparative Toxicogenomics...


  • Chennai, India FreeElective Network Full time

    TL;DR VERSION: FreeElective Network Pvt. Ltd., based in Chennai, introduced Jodi365.com—a next-generation matchmaking platform—well before the recent wave of here-today/gone-tomorrow casual dating sites and apps. Jodi365 caters exclusively to quality singles and helps them find the right partner at their own pace, whether they are ready for marriage in...

  • Associate Engineer

    1 week ago


    Chennai, India Sanmina Full time

    Job DescriptionBusiness Title: Associate Engineer – Equipment EngineeringDuties Of Position :1. Responsible of Downtime reduction and Co-ordinate with CFT for Process yield improvement.2. CAPA needs to be provided for major downtime and process related issues and Productivity improvement.3. Support for Product change over and Plan and execute all levels of...

  • Associate Engineer

    2 weeks ago


    chennai, India Sanmina Full time

    Job Description Business Title : Associate Engineer – Equipment Engineering Duties Of Position :1. Responsible of Downtime reduction and Co-ordinate with CFT for Process yield improvement.2. CAPA needs to be provided for major downtime and process related issues and Productivity improvement.3. Support for Product change over and Plan and...

  • Associate Engineer

    1 month ago


    Chennai, India Sanmina Full time

    Job Description Business Title : Associate Engineer – Equipment Engineering Duties Of Position : 1. Responsible of Downtime reduction and Co-ordinate with CFT for Process yield improvement. 2. CAPA needs to be provided for major downtime and process related issues and Productivity improvement. 3. Support for Product change over and Plan and...


  • Chennai, India Bhumi Full time

    This is a remote position.The Associate/ Senior Associate will be responsible for developing corporate relationships that promote retention and loyalty. This person will work closely with Corporate to ensure they are satisfied with the services they receive and to improve upon areas of employee engagement Primary responsibilities: Partner/Account...


  • Chennai, India Bhumi Full time

    Job Description This is a remote position. The Associate/ Senior Associate will be responsible for developing corporate relationships that promote retention and loyalty. This person will work closely with Corporate to ensure they are satisfied with the services they receive and to improve upon areas of employee engagement   Primary...


  • Chennai, India Bhumi Full time

    This is a remote position.The Associate/ Senior Associate will be responsible for developing corporate relationships that promote retention and loyalty. This person will work closely with Corporate to ensure they are satisfied with the services they receive and to improve upon areas of employee engagement Primary responsibilities: Partner/Account...


  • chennai, India Bhumi Full time

    Job Description This is a remote position. The Associate/ Senior Associate will be responsible for developing corporate relationships that promote retention and loyalty. This person will work closely with Corporate to ensure they are satisfied with the services they receive and to improve upon areas of employee engagement   Primary...

  • Associate

    1 month ago


    Chennai, India KKGS and Co Full time

    Qualified Chartered Accountants - CA Finalist - Articled Clerks - **Qualified Chartered Accountants**_ - Newly qualified Chartered accountants with sound experience during Articleship or a CA with 1-2 years’ experience in another CA firm and intends to practice in this noble profession with the firm in the Long run._ - **CA Finalists**_ - Associates who...


  • Chennai, India FreeElective Network Full time

    TL;DR VERSION: FreeElective Network Pvt. Ltd., based in Chennai, introduced Jodi365.com—a next-generation matchmaking platform—well before the recent wave of here-today/gone-tomorrow casual dating sites and apps. Jodi365 caters exclusively to quality singles and helps them find the right partner at their own pace, whether they are ready for marriage in...


  • Chennai, India Abbott Laboratories Full time

    MAIN PURPOSE OF ROLESummarize the main purpose of the role.Conduct market research and feasibility studies to analyze the viability of alternative business development opportunities.MAIN RESPONSIBILITIES•Collect, compile, verify, and analyze financial, competitive, sales, marketing, and other information about potential business partners, new markets,...


  • 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...


  • 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...