Regulatory Affairs

Sun Pharma; Gurugram District; On-site; INR 1,500,000 - 1,900,000; Full time

Job summary

Sun Pharma Gurgaon is seeking a Manager-2 to lead regulatory submissions for the US and OAM regions, manage lifecycle activities, and ensure timely approvals through quality dossiers.

You will review CMC dossiers, development and scale-up documents, specifications, stability protocols and validation data, coordinating with cross-functional teams. 8–12 years in regulatory affairs and an M.Pharma are required.

Qualifications

• Experience of USFDA market.
• Knowledge of CMC Module-1,2 & 3.
• CMC Dossier Preparation.
• Lifestyle Management.
• Cross-Functional Collaboration.

Responsibilities

• Regulatory submission of new products and variations for US and OAM regions.
• Review development reports, scale-up reports, specs, stability and validation.
• Respond to deficiency letters to enable product approvals.
• Lifecycle management: prepare variations, annual notices, labeling.
• Regulatory compliance including eCTD compilation and file changes.

Skills

USFDA experience

CMC Module knowledge

CMC Dossier Preparation

Cross-Functional Collaboration

Lifestyle Management

Education

M.Pharma

Job description

Job Title:

Manager-2

Business Unit:

Regulatory & Business Continuity

Job Grade

G11A

Location:

Gurgaon

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Key Responsibilities

Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.

Area Of Responsibility

1. New submissions:

Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.

Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy.

2. Approval:

• Review & prepare response to deficiency enabling approval of products filed to regulatory agency.

3. Lifecycle management for drug formulations:

Prepare and review variation, Annual notification and labelling approval for US and OAM

Review of change control and file variation as per country requirement

4. Regulatory compliance:

eCTD compilation

Ensure reposition of comprehensive product information into central repository

Review regulatory filing impact of variations, change controls, etc.

Competencies Required:

• Experience of USFDA market.
• Knowledge of CMC Module-1,2 & 3.
• CMC Dossier Preparation
• Lifestyle Management
• Cross-Functional Collaboration

Job Requirements

Educational Qualification –

M.Pharma

Experience –

Tenure: 8-12 Years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer:

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).