Cadila Hiring Regulatory Affairs

Cadila Pharma Regulatory Affairs Jobs | M.Pharm Gujarat

Cadila Pharmaceuticals hiring Senior Executive Regulatory Affairs. M.Pharm candidates with 2–5 years experience. Location: Dholka, Gujarat.

Pharmaceutical professionals looking for Regulatory Affairs jobs in the injectable segment have an excellent opportunity to join Cadila Pharmaceuticals Limited. The company is currently hiring for the position of Senior Executive – US Injectable Regulatory Affairs at its Dholka facility near Ahmedabad, Gujarat.

This opportunity is ideal for M.Pharm graduates with experience in injectable dosage forms and regulatory submissions for international markets. Candidates with expertise in USFDA regulations, dossier preparation, regulatory compliance, and injectable product filings can explore this career opportunity with one of India’s established pharmaceutical organizations.

As global pharmaceutical companies continue expanding their injectable product portfolios, demand for skilled Regulatory Affairs professionals has increased significantly. This position offers exposure to US regulatory filings, cross-functional collaboration, quality systems, and global pharmaceutical compliance processes.

Company Overview

Cadila Pharmaceuticals Limited is one of India’s leading pharmaceutical companies with a strong presence across domestic and international healthcare markets. The company is known for its commitment to innovation, quality manufacturing, research-driven development, and regulatory excellence.

Over the years, Cadila Pharmaceuticals has built a reputation for developing and manufacturing a wide range of pharmaceutical products that meet global quality standards. The organization operates advanced manufacturing facilities and serves patients across multiple countries through its diverse healthcare portfolio.

Working at Cadila Pharmaceuticals provides professionals with opportunities to contribute to global healthcare initiatives while gaining exposure to international regulatory frameworks, product development activities, and compliance-driven pharmaceutical operations.

Job Role & Responsibilities

Senior Executive – US Injectable Regulatory Affairs

This role is focused on supporting regulatory activities related to injectable pharmaceutical products intended for the United States market. The selected candidate will play a critical role in ensuring timely regulatory submissions and compliance with applicable global guidelines.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers for US injectable products.
• Coordinate preparation of regulatory documentation required for submissions.
• Handle regulatory queries, deficiency responses, and agency communications.
• Manage supplements, amendments, and variation submissions.
• Review critical development and quality documents related to injectable products.
• Evaluate stability, validation, sterility, and product development documentation.
• Initiate and manage Change Controls and Deviations.
• Maintain regulatory databases and submission records.
• Collaborate with cross-functional departments including QA, QC, Manufacturing, R&D, and Regulatory teams.
• Support timely product registrations and lifecycle management activities.
• Ensure compliance with current regulatory requirements and industry guidelines.

Regulatory Documentation Exposure

The role requires review and management of documents such as:

• Product Development Reports
• Stability Protocols and Reports
• Process Validation Documents
• Media Filter Validation Reports
• Sterility Documentation
• Test Procedures
• Product Specifications
• Change Control Documentation
• Regulatory Submission Records

Required Technical Knowledge

Candidates should possess working knowledge of:

• USFDA Regulations
• ICH Guidelines
• Injectable Product Registration Requirements
• Regulatory Submission Processes
• Pharmaceutical Quality Systems
• GMP Documentation
• Validation and Stability Requirements
• Data Integrity Principles
• Regulatory Compliance Management

Eligibility / Qualifications

Educational Qualification

• M.Pharm (Mandatory)

Relevant Courses

M.Pharm Pharmaceutics, M.Pharm Pharmaceutical Analysis, M.Pharm Quality Assurance, M.Pharm Regulatory Affairs, M.Pharm Industrial Pharmacy, M.Pharm Drug Regulatory Affairs.

Experience Requirement

• 2 to 5 Years

Preferred Candidate Profile

The ideal candidate should have:

• Experience in Injectable Dosage Forms.
• Exposure to US regulatory filing requirements.
• Knowledge of dossier preparation and lifecycle management.
• Understanding of pharmaceutical validation documentation.
• Experience handling regulatory deficiencies and agency queries.
• Strong documentation and communication skills.
• Ability to coordinate with multiple departments and stakeholders.

Why Join Cadila Pharmaceuticals?

Cadila Pharmaceuticals offers a professional environment where employees contribute directly to global healthcare initiatives. Regulatory Affairs professionals joining the organization gain valuable experience in international pharmaceutical regulations and injectable product registrations.

Benefits of Joining

• Opportunity to work on global regulatory projects.
• Exposure to US Injectable product filings.
• Experience with USFDA and ICH compliance requirements.
• Career growth in Regulatory Affairs and Pharmaceutical Compliance.
• Collaborative and knowledge-driven work culture.
• Professional development opportunities in global healthcare markets.
• Exposure to international regulatory submission strategies.

For professionals aspiring to build long-term careers in Regulatory Affairs, Pharmaceutical Compliance, Drug Registration, Regulatory Consulting, and Global Product Management, this position offers valuable industry exposure.

Location & Salary

Location: Dholka, Near Ahmedabad, Gujarat

Approximate Salary: ₹6.0 LPA – ₹10.5 LPA

Actual compensation may vary based on experience, technical expertise, regulatory exposure, and company evaluation.

Application Process

Interested and eligible candidates can apply by sending their updated resume through email.

Email Application

Email ID: savitri.thakor@cadilapharma.com

Subject Line Format

Candidates should mention:

“Application for Senior Executive – US Injectable Regulatory Affairs”

Documents Recommended

• Updated Resume
• Educational Qualification Certificates
• Experience Certificates
• Current CTC Details
• Notice Period Information

Early applications are recommended as candidate screening may begin before the position is closed.

Frequently Asked Questions (FAQs)

1. What position is Cadila Pharmaceuticals hiring for?

Cadila Pharmaceuticals is hiring for the role of Senior Executive – US Injectable Regulatory Affairs.

2. What qualification is required for this position?

Candidates must possess an M.Pharm degree.

3. Is experience in injectable products mandatory?

Yes, the company has specifically mentioned expertise in Injectable Dosage Forms as a key requirement.

4. How much experience is required?

Applicants should have 2 to 5 years of relevant Regulatory Affairs experience.

5. What regulatory knowledge is expected?

Candidates should have knowledge of USFDA regulations, ICH guidelines, dossier preparation, supplements, variations, and regulatory compliance activities.

6. Where is the job location?

The position is based at Dholka, near Ahmedabad, Gujarat.

Summary

Company	Cadila Pharmaceuticals Limited
Department Vacancies	Senior Executive – US Injectable Regulatory Affairs
Qualification	M.Pharm
Experience	2–5 Years
Location	Dholka, Gujarat