Senior Manager -Regulatory And Business Continuity USFDA CMC

SUN PHARMA; Gurgaon; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Sun Pharma, located in Gurgaon, seeks a Sr. Manager-2 to lead regulatory submissions for US and OAM regions. The role focuses on CMC dossier preparation, lifecycle management, and cross-functional collaboration to ensure timely approvals.

Educational requirement is M.Pharma with 13–18 years of experience in regulatory affairs. This position is based on-site in Gurgaon and offers robust growth opportunities within Regulatory & Business Continuity.

Qualifications

• Experience with US FDA regulatory requirements.
• Expertise in CMC content for regulatory submissions.
• Ability to manage lifecycle changes and approvals.

Responsibilities

• Regulatory submissions of new products and variations for US and OAM regions.
• Prepare and review CMC dossiers and support exhibit batches for adequacy.
• Coordinate change controls and filing impacts across country requirements.

Skills

USFDA market

CMC Module-1,2 & 3

CMC Dossier Preparation

Lifecycle Management

Cross-Functional Collaboration

Education

M.Pharma

Job description

Job Description:

Job Title: Sr. Manager-2

Business Unit: Regulatory & Business Continuity

Job Grade: G9B

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.

Competencies Required:

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

Job Requirements

Educational Qualification – M.Pharma

Experience – Tenure: 13-18 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).