Pfizer Hiring Freshers Pharma Associate – Candidates Apply Online
Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and the potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
Job Title: Associate II
Location: India – Chennai
Qualifications
- Master’s Degree in Science/Pharmacy/Engineering with 0 – 2 years of experience in Pharma/Biopharma industry (preferably regulatory affairs)
- Proven ability to manage complex regulatory or drug development issues
- Basic Knowledge of the regulations and guidelines in the various markets (esp. US and EU)
- Good skills on communication, collaboration, negotiation and problem solving
Fluent in English, written and spoken - Computer literacy and the ability to learn new systems
Nice-to-Have
- Knowledge of regulatory processes and documents, knowledge of therapeutic areas
- Thinks strategically with good project management skills
- Prior Annual Report Experience
Job Responsibilties:
- Compilation and submission of Annual Reports (AR) for the US Market
Work with cross-functional stakeholders across geographies to ensure timely dispatch of the Annual Report as per the CFR (Code for Federal Regulation Timelines) - Efficiently use the Pfizer tools such as PDM, GDMS, TrackWise for authoring the annual reports
- Proficient in retrieving information from the US FDA, DailyMed websites for labeling information
- Resolution of issues including timely communication/escalation of issues, impact, and the outcomes to global regulatory management and core team.
- Complies with all standards, procedures, and policies for submissions set forth for the Regulatory Function.
- Demonstrate ability to work with minimal to no supervision in preparing applications
Stay knowledgeable about current regulations and guidance to perform day to day regulatory activities and showcase knowledge development through team presentations - Ensures compliance to Pfizer’s internal procedures and training SOPs i.e. P2L and PCEC
Have great attention to detail during the application preparation - Familiar with basic CMC (Chemistry, Manufacturing, and Controls) aspects of regulatory affairs.
Apply Online
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