Associate I

2 months ago

Chennai, India Pfizer Full time

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: On Premise

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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