Associate II – Reg CMC Strategy, Brands CMC

Spread the love

Location: India – Chennai

Time type: Full time
Posted on Posted Today
Job requisition id: 4904888
Manages day-to-day regulatory activities associated with assigned Renewals within agreed upon timelines under the guidance of Team Lead / designee.   Has fundamental knowledge of the principles and concepts of process been followed, the activities which includes but not limited to:
 
  • Provides support to renewal strategist in preparation of the CMC contributions for Renewal applications for the assigned products for global markets.
  • Authors and/or compiles 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. Supports Query and/or commitment management in collaboration with GRS-CMC.
  • Reviews technical/supportive information for submission to support renewals.
  • Updates impacted dossier components as needed. Escalates delays in timelines and contributes to the Identification and mitigation of 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.

See All 👉D.Pharmacy Alerts👈 👉B.Pharmacy Alerts👈👉M.Pharmacy Alerts👈👉B.Sc Alerts👈👉M.Sc Alerts👈 👉Other Life Science Alerts👈

See All 👉Other Jobs👈in our Database

 

Preferred Education: Minimum – Undergraduate/Postgraduate in Pharmacy or Science  
 
Preferred Experience: Minimum 2 – 4 Years 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 details.  
 
Technical Skills:
  • Knowledge on Regulatory requirements of post approval changes for global market.
  • 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: 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-PFE
 

See All 👉D.Pharmacy Alerts👈 👉B.Pharmacy Alerts👈👉M.Pharmacy Alerts👈👉B.Sc Alerts👈👉M.Sc Alerts👈 👉Other Life Science Alerts👈

See All 👉Other Jobs👈in our Database

Job Interview: Decoding Interview

(If You want to clear your interview this book will help you)


Spread the love

Leave a Reply

Your email address will not be published. Required fields are marked *