Science Graduates, Postgraduates Vacancy at Pfizer

Overview:

Pfizer is hiring an experienced Associate II – Reg CMC, Strategy, Brands LCM at their Chennai location. This role 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 complete details of this job are as follows:

Roles and Responsibilities:

• 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 Identified 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.

Qualifications:

• Minimum – Undergraduate/Postgraduate in Pharmacy or Science
• Proven ability to manage complex regulatory or drug development issues
• Knowledge of the regulations and guidelines in the various markets
• Strong relationship with the local health agency and other relevant stakeholders and pro-actively manages issues with key external stakeholders
• Good skills on communication, collaboration, negotiation and problem solving
• Fluent in English, written and spoken
• Computer literacy and ability to learn new systems

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.

Disclaimer: The Recruitment Information provided above is for informational purposes only. The above Recruitment Information has been taken from the official site of the Organisation. We do not provide any Recruitment guarantee. Recruitment is to be done as per the official recruitment process of the company or organization posted the recruitment Vacancy. We don’t charge any fee for providing this Job Information. Neither the Author nor Studycafe and its Affiliates accepts any liabilities for any loss or damage of any kind arising out of any information in this article nor for any actions taken in reliance thereon.