Manager -2

Sun Pharmaceutical Industries, Inc.; Gurugram District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd in Gurgaon is seeking a Manager-2 to lead regulatory submissions for US and other regions. The role involves preparing CMC dossiers, handling lifecycle management, and ensuring eCTD compilation with cross-functional teams to support timely approvals.

The candidate should have MP pharma qualifications, with strong USFDA experience and expertise in regulatory compliance. This position is based on-site in Gurgaon with competitive benefits.

Qualifications

• Regulatory submissions for new products and variations.
• Experience with USFDA filings and lifecycle management.
• M.Pharma in a relevant field is required.

Responsibilities

• Regulatory submission of new products and variations for US and other regions.
• Review & prepare CMC dossiers for filings and quality dossiers.
• Support the approval process by addressing deficiency responses.
• Lifecycle management for drug formulations and labeling approvals.
• Ensure eCTD compilation and regulatory filing compliance.
• Collaborate with cross-functional teams across functions.

Skills

Regulatory submissions

CMC dossier

eCTD

Lifecycle management

USFDA experience

Cross-functional collaboration

Education

M.Pharma

Tools

Regulatory databases

CMC documentation tools

Job description

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Company: Sun Pharmaceutical Industries Ltd

Job Title:

Manager-2

Business Unit:

Regulatory & Business Continuity

Job Grade

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

• 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.
• Approval:
• Review & prepare response to deficiency enabling approval of products filed to regulatory agency.
• 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
• Regulatory compliance:
• eCTD compilation
• Ensure reposition of comprehensive product information into central repository
• Review regulatory filing impact of variations, change controls, etc.
• Experience of USFDA market.
• Knowledge of CMC Module-1,2 & 3.
• Lifecycle Management
• Cross-Functional Collaboration

Job Requirements

Educational Qualification –

M.Pharma

Experience –

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).