Senior Manager -Regulatory & Business Continuity USFDA

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?

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
• 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!
• Experience –

Experience –

• 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).