Pfizer Regulatory Affairs fresher and experienced job vacancies in Chennai for Undergraduate/Postgraduate Pharmacy or Science students
Pfizer is a leading global biopharmaceutical company with a history of over 170 years. It is committed to discovering innovative medicines that can help improve the health and well-being of people worldwide. Pfizer’s portfolio includes the world’s most well-known and respected primary care, specialty care, oncology, and vaccine brands. The company is headquartered in New York City and operates in over 150 countries worldwide.
Associate I – Reg CMC Strategy, Brands CMC
locations; India – Chennai
job requisition id; 4882250
Manages day-to-day regulatory activities associated with assigned Renewals within agreed-upon timelines under the guidance of the Team Lead / designee.
Has fundamental knowledge of the principles and concepts of process been followed, the activities which include but are not limited to:
- Provides support to renewal strategists in preparation of the CMC contributions for Renewal applications for the assigned products for global markets.
- Authors and/or compile CMC contributions for renewals, i.e., Module 1, M2.3.S/P, M3.2.S/P/R/A. Collaborates with GRS-CMC/RRHS as appropriate and within agreed timelines.
- Liaise with Pfizer Global Supply and other support functions as needed.
- Applies pertinent regulatory guidelines for authoring renewals.
- Executes renewals regulatory strategy while considering registered content and seeks endorsement by the GRS-CMC/RRHS.
- Reviews technical/supportive information for submission to support renewals.
- Updates impacted dossier components as needed. Escalates delays in timelines and contributes to identifying and mitigating risks with the support of TL/designee; flags identified risks to the CMC GRL and/or appropriate leadership.
- Coordinates M1/M3.2.R Ancillary documents as needed.
- Coordinates internal document review and sign-off.
- Utilizes Pfizer’s systems, i.e., PEARL, GDMS, PDM, SPA, etc., as appropriate.
- Preferred Education: Minimum – Undergraduate/Postgraduate in Pharmacy or Science
- Preferred Experience: Minimum 0 – 1 Year in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization
- Preferred Attributes: Excellent oral and written English communication skills. Good conceptual, analytical, problem-solving, and organizational skills. Good conceptual and reasoning skills. Attention to detail.
- Technical Skills:
- Knowledge of Regulatory requirements of post-approval changes for the global market.
- Knowledge in retrieving information from company and regulatory agency databases.
- Basic knowledge of general standards, processes, and policies of the 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.
