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Trainee Executive - Regulatory Affairs

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 Trainee Executive - Regulatory Affairs

Job Description

Manages day-to-day regulatory activities associated with assigned Renewals within agreed upon timelines under the guidance of Team Lead / designee.

Has fundamental knowledge of the principles and concepts of process being followed, the activities which includes but not limited to :

  • Provides support to renewal strategist in preparation of the CMC contributions for Renewal applications for the assigned products for global markets
  • Liaise with Pfizer Global Supply and other support functions as needed.
  • Use of regulatory systems and management of CMC documentation and information in support of the GRS-CMC/RRHS.
  • Reviews and applies pertinent regulatory guidelines for authoring renewals
  • Develops initial renewals regulatory strategy while considering registered content and seeks endorsement by the GRS-CMC/RRHS.
  • Authors and/or compiles CMC contributions for renewals, i.e. Module 1, M2.3.S/P, M3.2.S/P/R/A under guidance from renewal Strategist /GRS-CMC/RRHS as appropriate and within agreed timelines.
  • Reviews technical/supportive information for submission to support renewals
  • Develops technical justification of change for agency submission as needed
  • Updates impacted dossier components as needed
  • Coordinates M1/ M3.2.R Ancillary documents as needed
  • Escalates delays in timelines and flags identified risks to the GRS-CMC and/or appropriate leadership
  • Coordinates internal document review and sign off.
  • Utilizes Pfizer s systems, i.e . PEARL, GDMS, PDM, SPA, etc, as appropriate.
  • Ensure compliance to assigned P2L and Pfizer compliance trainings.

Job Classification

Industry: Engineering & Construction
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: Drug Regulatory Affairs/Documentation
Role: Drug Regulatory Affairs/Documentation
Employement Type: Internship

Education

Under Graduation: Any Graduate
Post Graduation: Any Postgraduate
Doctorate: Doctorate Not Required

Contact Details:

Company: Pfizer
Location(s): Chennai

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Keyskills:   Training Executive Document review Executive Regulatory Affairs Compliance CMC Management Regulatory affairs

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