Senior Executive - FRD Orals

SUN PHARMA; Vadodara; On-site; INR 600,000 - 900,000; Full time

Job summary

Sun Pharma in Baroda is seeking a Senior Executive for the R&D1 Regulatory Affairs team. You will conduct literature search, interpret data, contribute to product development planning, and help prepare strategy discussions with group leaders.

This role requires a strong foundation in pharmaceutical science and hands-on experience in regulatory-related activities. The position offers growth opportunities in a collaborative environment at Sun Pharma, with responsibilities spanning scale-up

Qualifications

• M. Pharm is required.
• 4–8 years of experience in regulatory affairs or related field.
• Experience with product development and batch documentation.
• Strong written and verbal communication.

Responsibilities

• Literature search, product understanding, data interpretation for development.
• Design of primary product strategy, preparation of product strategy for discussion with group leader/team leader.
• Planning and execution of product development work to achieve desired product profile and data compilation
• Scheduling the work plan in consultation with group leader/ reporting authority for timely completion of the projects.
• Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation
• Laboratory notebook writing and assistance in documentation of controlled documents and compilation of the development data
• Execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufacturing locations.
• Preparation of document for smoothly execution of scale up and exhibit batches like Justification of specification, QbD elements, MFC etc

Skills

Literature search

Data interpretation

Product development planning

Documentation

Education

M. Pharm

Job description

Job Title

Senior Executive

Business Unit

R&D1 Regulatory Affairs

Job Grade

G11B

Location

Baroda

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.”

Job Description

• Literature search, product understanding, data interpretation for product to be undertaken for development.
• Design of primary product strategy, preparation of product strategy for discussion with group leader/team leader.
• Planning and execution of product development work to achieve desired product profile and data compilation
• Scheduling the work plan in consultation with group leader/ reporting authority for timely completion of the projects based on priority assigned.
• Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation
• Laboratory notebook writing and assistance in documentation of controlled documents and compilation of the development data
• Execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufacturing locations.
• Preparation of document for smoothly execution of scale up and exhibit batches like Justification of specification, QbD elements, MFC etc

Travel Estimate

NA

Job Requirements

Educational Qualification

M. Pharm

Experience

Tenure : 4 – 8 Yrs.

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).