Freshers Pharma Job at Pfizer
Job Title: Associate I – Reg CMC Strategy, Brands CMC
Location: India – Chennai
Job Type: Full Time
Job ID: 4901451
- 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.
- 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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