Pharmaceutical Regulatory Affairs Manager

Clinical Research

11 hours ago

Delhi, New Delhi

₹ 100K - 150K

Communication

Documentation

HPLC

Inventory

Job Description

A Pharmaceutical Regulatory Affairs Manager is responsible for ensuring that pharmaceutical products comply with all national and international regulations before they are marketed. This role acts as a bridge between pharmaceutical companies and regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency.They prepare, review, and submit regulatory documents to gain approval for new drugs and maintain compliance throughout the product lifecycle.

Key Responsibilities

Regulatory Strategy DevelopmentDevelop and implement regulatory strategies for product approvalProvide guidance on regulatory requirements for new drug developmentEnsure compliance with global regulatory standards2️⃣ Documentation & SubmissionPrepare and submit regulatory documents such as:IND (Investigational New Drug applications)NDA (New Drug Applications)ANDA (Abbreviated New Drug Applications)Review technical documents for accuracy and compliance3️⃣ Liaison with Regulatory AuthoritiesCommunicate with agencies like U.S. Food and Drug AdministrationRespond to queries and provide additional documentation when requiredAttend regulatory meetings and inspections4️⃣ Compliance MonitoringEnsure company procedures follow:Good Manufacturing Practices (GMP)Good Clinical Practices (GCP)Monitor changes in pharmaceutical laws and update internal policies5️⃣ Product Lifecycle ManagementManage post-approval changesHandle product renewals and variationsOversee labeling updates and safety reports6️⃣ Risk Assessment & Quality AssuranceIdentify regulatory risksDevelop mitigation strategiesWork closely with quality assurance and clinical teams7️⃣ Team LeadershipLead regulatory affairs team membersTrain staff on regulatory updatesCoordinate cross-functional departments

Skill & Experience

Interpersonal Skill
Leadership Skill
Problem-solving Skill
Time management Skill
Compliance

Job Overview

Date Posted:

2nd Mar, 2026

Expiration date:

24th Apr, 2026

Location:

Delhi, India

Job Type:

Full-Time

Job Shift:

Full - Time

Functional Areas:

Analytical Development

Positions:

Job Experience:

6 Year

Company Overview

NovaCure Pharmaceuticals Pvt. Ltd.

View company profile

Founded in:

1900

Phone:

7898447653

Location:

76th Floor, Orion Tech Park HITEC City, Madhapur Hyderabad, TelangaUnit 302, Prestige Omega EPIP Zone, Whitefield Bengaluru, Karnataka – 560066 Indiana – 500081 India

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