Pfizer

Actively Hiring

Regulatory Affairs Manager

Delhi, India

Full time

Role Overview

The person will be responsible for overseeing strategy relating to obtaining, managing and maintaining product Marketing Authorization's and support Clinical Trial Authorization's in line with business goals and legal requirements.

About Pfizer

Pfizer is a leading global biopharmaceutical company applying science and our global resources to bring therapies to people that extend and significantly improve their lives.

Key Responsibilities

Deliver Regulatory Strategy and Advise Cross-Functional Teams
Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests
Manage New Registration/Marketing Authorization Applications
Manage Marketing Authorisation Variation Applications
Manage MA Renewal Applications
Management of NRA queries
Support strategic clinical development activities
Populate and Maintain Regulatory Databases

Requirements & Eligibility

Expert knowledge of national legislation, guidelines and regulatory environment
Experience in developing and delivering optimal regulatory strategies

Required Skills & Tech

Regulatory SciencesRegulatory StrategyComplianceClinical Trials