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Freshers Pharma Job at Pfizer

Job Title: Associate I – Reg CMC Strategy, Brands CMC

Location: India – Chennai

Job Type: Full Time

Job ID: 4901451

Job Description

  • Manages day-to-day regulatory activities associated with assigned Annual Reports within agreed upon timelines.
  • Reviews changes made during the reporting period for completeness and accuracy. Develops initial Annual Report regulatory strategy while considering registered content and seeks endorsement by the CMC GRL.
  • Authors and/or compiles CMC contributions based on changes made during the appropriate reporting period, i.e. Module 1 & 3 under the guidance from the CMC GRL as appropriate and within agreed timelines.
  • Reviews all appropriate systems for post approval changes submitted and approved along with commitments made and fulfilled.
  • Reviews technical/supportive information for submission to support AR changes.
  • Manages and reviews stability contributions for accuracy and consistency with commitments.
  • Reviews and applies pertinent US regulatory guidelines to confirm Annual Reportable filing classifications.
  • Develops technical justification of change for agency submission as needed.
  • Updates impacted dossier components as needed.
  • Coordinates M3.2.R Ancillary documents as needed.
  • Escalates delays in timelines and flags identified risks to the CMC GRL and/or appropriate leadership.
  • Coordinates internal document review and sign off.
  • Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc., as appropriate.
  • Ensures compliance to Pfizer internal procedures and training SOPs (PLA).

Preferred Education : Minimum – Postgraduate in Pharmacy / Science

Preferred Experience

: Minimum 0 – 1 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization. Excellent oral and written English communication skills. Good conceptual and reasoning skills. Attention to details.

Preferred Attributes : Excellent oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills. Good conceptual and reasoning skills. Attention to details.

Technical Skills

  • Regulatory requirements of post approval changes for US
  • Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of ARs.
  • Knowledge in retrieving information from company’s and regulatory agency databases.
  • Basic level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry.

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.


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