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.
- 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.
List of Competencies Required:
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
- 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.
- 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.
