Executive Sr Executive -Regulatory And Business Continuity

SUN PHARMA; Dewas; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Sun Pharma in Dewas is seeking an Exe / Sr. Exe in Regulatory & Business Continuity to contribute to the product registration lifecycle.

You will review data and documents for registrations, compile dossiers for US FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel, and prepare responses to deficiency letters.

Educational qualification is B. Pharma or M. Pharma and 6–8 years of relevant experience; Sun Pharma offers opportunities for growth and professional development.

Qualifications

• Educational qualification: B. Pharma / M. Pharma.
• Experience: 6-8 years.
• Experience in regulatory submissions preferred.

Responsibilities

• Review all data and documents related to product registrations for various health authorities.
• Compile registration dossiers for submission to health authorities like US FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
• Prepare responses to deficiency letters received from various agencies.
• Maintain life-cycle / post approval changes for drug product registration dossiers.
• Provide regulatory support to cross functional departments.
• Prepare and submit scientific advice to various health authorities.
• eCTD compilation, verification and submission through electronic gateway.
• Review, preparation and submission of annual reports to US FDA.
• Review, preparation and submission of post approval supplements to US FDA.

Education

B. Pharma / M. Pharma

Job description

Job Description:

Job Title

Exe / Sr. Exe

Business Unit

Regulatory & Business Continuity

Job Grade

G12A /G11B

Location:

Dewas

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

• Review all data and documents related to product registrations for various health authorities.
• Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
• Prepare responses to deficiency letters received from various agencies.
• Maintain life-cycle / post approval changes for drug product registration dossiers.
• Provide regulatory support to cross functional departments.
• Prepare and submit scientific advice to various health authorities.
• eCTD compilation, verification and submission through electronic gateway
• Review, preparation and submission of annual reports to US FDA
• Review, preparation and submission of post approval supplements to US FDA

Job Requirements

Educational Qualification –

B. Pharma / M. Pharma

Experience –

Tenure : 6-8 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).