Trainee Executive

3 weeks ago

Chennai, India Pfizer Full time

Pfizer Essential Health Global Regulatory Affairs (PEH GRA) Job Description (JD)

Job Title: Annual Report Strategist (CMC)/ Trainee Executive

Organization : PEH GRA

Line (if applicable): India Strategy

Department/Group (if applicable) : Legacy Brands CMC - NDA Annual Report

Region and/or Country (if applicable) : Not Applicable

Version Date: 31-Oct-2017

Organizational Relationship(s) including to whom the position reports (JD Job Title):
Position reports to Manager, Legacy Brands NDA AR CMC.

Position Purpose

Functions as an Annual Report Strategist for Brands-NDA Annual Report (AR) team, working with CMC Global Regulatory Strategist - CMC (GRS-CMC) and Cross Functional Teams to prepare and submits the CMC contributions of US NDA/ANDA/BLA/PMA/IND Annual Reports as per defined timelines.

Primary Responsibilities
- 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 (Power 2 Learn).

Technical Skill Requirements
- Knowledge on 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.

Qualifications (i.e., preferred education, attributes)
- Preferred Education:
Minimum - Postgraduate in Pharmacy / Science
- Preferred Attributes:
Excellent oral and written English communication skills. Good conceptual and reasoning skills. Attention to details.

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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