Sun Pharma Hiring Executive Regulatory Affairs in Baroda for M.Pharm candidates with CDSCO submission experience and regulatory career growth opportunities.
Sun Pharma Hiring Executive Regulatory Affairs (India) in Baroda | M.Pharm with 3 Years Experience
Sun Pharmaceutical Industries Ltd has announced a new opportunity for regulatory affairs professionals looking to grow in India-focused regulatory submissions. The company is hiring for the role of Executive – Regulatory Affairs (India) at its R&D location in Baroda. This role is suitable for candidates with hands-on experience in Indian regulatory submissions and CDSCO compliance.
Professionals with expertise in dossier compilation, regulatory documentation review, and coordination with cross-functional teams can explore this opportunity. The position offers a chance to work with one of India’s largest pharmaceutical companies and contribute to regulatory approvals across multiple product categories. Sun Pharma Hiring Executive Regulatory Affairs
Company Overview
Sun Pharmaceutical Industries Ltd is one of the largest pharmaceutical companies in India and a leading global generic drug manufacturer. With a strong presence across formulations, APIs, specialty medicines, and R&D innovation, the company operates in over 100 countries.
Sun Pharma is known for its robust regulatory infrastructure and commitment to innovation, making it a preferred employer for professionals in regulatory affairs, quality, and research domains. Sun Pharma Hiring Executive Regulatory Affairs
Job Location & Employment Type
- Company: Sun Pharmaceutical Industries Ltd
- Job Title: Executive – Regulatory Affairs (India)
- Department: R&D Regulatory Affairs
- Location: Baroda (Vadodara), Gujarat
- Employment Type: Full-time
- Job Grade: G12A
Department Overview
This role is part of the India Regulatory Affairs division within the R&D function. The selected candidate will be responsible for managing regulatory submissions and approvals within India, primarily interacting with CDSCO and related authorities.
The role involves working closely with CMC teams, quality functions, and regulatory stakeholders to ensure timely approvals for drug substances and finished formulations. Sun Pharma Hiring Executive Regulatory Affairs
Key Roles & Responsibilities
The Executive – Regulatory Affairs will be responsible for managing India-specific regulatory activities, including:
- Evaluating regulatory strategies for product registrations in India
- Reviewing CMC and supporting regulatory documents
- Coordinating with cross-functional teams for document corrections
- Preparing application cover letters and regulatory documentation
- Compiling dossiers for submission to CDSCO headquarters and zonal offices
- Handling submissions related to clinical trials and bioequivalence studies
- Managing import and marketing approval applications in India
- Preparing IPC testing dossiers and coordinating sample submissions
- Supporting post-approval regulatory variations and lifecycle changes
- Handling Phase IV clinical trial submissions
- Managing additional site approval and notifications
- Preparing permissions for export-related BE studies
- Handling regulatory permissions such as:
- CT-10 / CT-12 / CT-13 (test or analysis manufacturing permissions)
- Form 11 / CT-17 (import for testing permissions)
- Form 8 import approvals
- Reviewing product labeling and artwork for regulatory compliance
This role requires strong knowledge of Indian regulatory frameworks and submission procedures. Sun Pharma Hiring Executive Regulatory Affairs
Eligibility Criteria
Educational Qualification
- M.Pharm (Mandatory)
Experience Requirements
- Minimum 3 years of relevant experience in regulatory affairs
- Experience in Indian regulatory submissions preferred
- Hands-on exposure to CDSCO documentation and filings is advantageous
Skills Required
- Strong understanding of Indian regulatory guidelines
- Knowledge of CDSCO submission processes and formats
- Expertise in dossier compilation and regulatory documentation
- Ability to coordinate with CMC and cross-functional teams
- Attention to detail in labeling and artwork compliance
- Strong written communication and documentation skills
- Ability to manage multiple submissions simultaneously
Salary & Benefits
- Compensation will be offered as per company norms
- Opportunity to work with India’s leading pharmaceutical company
- Exposure to India regulatory strategy and lifecycle submissions
- Career growth within regulatory affairs and R&D domains
- Collaborative and growth-oriented work environment
Sun Pharma is known for offering structured growth and strong learning exposure in regulatory functions.
Selection Process
The recruitment process may include:
- Online application submission
- HR screening
- Technical interview focusing on regulatory knowledge
- Final managerial discussion
- Offer release and onboarding
Candidates with prior India regulatory exposure may have an advantage during evaluation. Sun Pharma Hiring Executive Regulatory Affairs
How to Apply
Interested candidates can apply through the official careers portal of Sun Pharmaceutical Industries Ltd. Ensure your profile highlights:
- CDSCO submission experience
- Dossier compilation expertise
- Regulatory lifecycle management exposure
- Cross-functional coordination experience
Applying early is recommended due to competitive demand for regulatory roles in top pharma companies.
Important Dates
- Application deadline: Not specified
Candidates are encouraged to apply as early as possible.
Why Apply for This Pharma Job?
Regulatory affairs roles focused on domestic markets are critical for professionals aiming to specialize in Indian regulatory frameworks. This opportunity offers direct exposure to CDSCO submissions, regulatory lifecycle management, and dossier compilation for multiple product types.
Working at Sun Pharma provides credibility and stability, along with the opportunity to build deep expertise in India-focused regulatory pathways. Professionals in such roles often transition into senior regulatory strategy or global submission roles later in their careers.
For candidates aiming to grow within regulatory affairs and gain experience with a leading pharma brand, this role presents a strong career-building opportunity. Sun Pharma Hiring Executive Regulatory Affairs
Important Note
IndiaPharmaJobs.in is an independent job information platform that provides verified updates related to pharmaceutical and healthcare careers. We are not affiliated with Sun Pharmaceutical Industries Ltd or any recruitment agency. Applicants should apply through official company channels and verify all details independently. Sun Pharma Hiring Executive Regulatory Affairs
Final Words
If you are an M.Pharm graduate with experience in Indian regulatory affairs, this opportunity with Sun Pharma offers a strong platform to advance your career. With exposure to CDSCO submissions and regulatory lifecycle management, the role provides both stability and growth potential. Apply through the official careers portal to explore this opportunity with one of India’s leading pharmaceutical companies. Sun Pharma Hiring Executive Regulatory Affairs
