Associate Ii

2 weeks ago

Chennai, India Pfizer Full time

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:

- 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**:
Must-Have
- 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.

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

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