Associate Manager II
Pfizer Inc.
Chennai, India
Job posting number: #7136977 (Ref:pf-4881239)
Posted: March 29, 2023
Application Deadline: Open Until Filled
Job Description
Functions as the CMC author / strategist for the Life Cycle Management (LCM) activities of assigned projects providing regulatory assessments and developing regulatory strategies.
Acts as the global CMC representative within cross-functional project teams for the assigned projects. Accountable for assigned projects and activities, completing work within assigned changes. Develops resolution proposals for regulatory CMC issues with the stakeholders.
Reviews proposed CMC changes for completeness and accuracy, interpret CMC regulatory requirements , develops strategies, assess risks and develops contingency proposals.
Use technical and scientific knowledge to conduct the analysis of CMC submission documentation.
Responsible for the authoring of CTD sections (Module 3 and QOS) and review of CMC documentation, coordination and management of global submissions.
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.
Regulatory Affairs#LI-PFEPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Apply Now
Please mention to the employer that you saw this ad on Sciencejobs.org
- Share this job:
- [Save this Job]
