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.”
List of Responsibilities / Job Functions
Development of robust, stable, cost effective, scalable processes/ products, bioequivalent formulations, meeting the desired quality standards, for regulatory filings as per business plan.
Design formulation development strategy and carry out discussion with cross functional team from IP, Regulatory and Manufacturing to assess suitability and feasibility.
Review the design of experiments and studies to ensure adequacy during product development and discuss the outcomes, issues and improvements required.
Planning and execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufacturing locations, in consultation with group leader.
Provide support for execution and troubleshooting of scale up/ Technology transfer to facilitate timely execution of exhibit batches
Ensuring the compliance of the various SOP/guideline/general procedures for better functioning of the department.
Generate requisite technical data packages, development reports etc.
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Providing technical inputs related to product development to RA on any query raised by regulatory agencies post submission/ filing of new products and/ re-registration of products.
Perform research in full compliance with current GxP, SOPs and regulatory requirements and in accordance with established safety standards.
Technical Competencies:
PhD in Pharmaceutical Science
9 years of experience in Pharma Industry
Thorough knowledge of product development
Behavioral Competencies / Soft Skills:
Communication skills
Collaboration and team work
Decision making skills
Analytical thinking
Experience
Significant experience in Clinical Quality, Clinical Operations, and/or Regulatory Compliance.
Direct and recent experience supporting or leading global GxP regulatory inspections.
Strong working knowledge of GxP regulations, ICH guidelines, and global inspection processes and CAPA.
Experience collaborating with CROs and third‑party vendors.
Skills Required
Demonstrated ability to manage complex, high‑pressure situations with a structured, organized approach.
Strong written and verbal communication skills, including experience interacting directly with Health Authority inspectors.
In‑depth understanding of R&D regulatory requirements and inspection expectations.
Proven ability to influence without authority across functions, levels, and geographic regions.
Strong problem‑solving, risk assessment, and analytical capabilities.
Experience with digital inspection readiness tools and document management systems.
Ability to operate effectively in a global, matrixed pharmaceutical organization.
Travel Estimate
Job Requirements
Educational Qualification
Master’s degree preferred.
Experience
Tenure: 10+ 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!
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