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Research Associate – Regulatory Affairs | Cadila Pharma Dholka
Cadila Pharmaceuticals hiring Research Associate (Regulatory Affairs) with 3+ yrs exp at Dholka, Ahmedabad. Apply now!
Cadila Pharmaceuticals Ltd., a leading name in global pharmaceutical manufacturing and research, is seeking a talented Research Associate – Regulatory Affairs to join its Dholka (Ahmedabad) facility. This is an excellent opportunity to contribute to regulatory compliance, DMF submissions, and global pharma projects, while growing your career in a high-impact role.
Company Overview
Cadila Pharmaceuticals Ltd. is a globally recognized pharmaceutical company dedicated to innovation, quality, and healthcare excellence. With a strong presence in regulated and semi-regulated markets, Cadila provides cutting-edge solutions across APIs, formulations, and research services. Their Dholka facility specializes in Regulatory Affairs, analytical development, and quality assurance, making it an ideal workplace for professionals looking to advance their careers in pharma compliance and documentation.
Job Role & Responsibilities
Position: Research Associate – Regulatory Affairs
Location: Dholka, Ahmedabad
Experience: Minimum 3 years
Qualification: B.Pharm, M.Pharm, or relevant life sciences degree
Key Responsibilities:
- Preparation, review, and submission of Drug Master Files (DMFs) for regulated and semi-regulated markets.
- Handle DMF submissions, annual updates, and responses to authorities including US, Canada, China, and Korea (via eCTD/CTD formats).
- Prepare and respond to EDQM submissions through CESP in eCTD format.
- Develop closed-part DMFs for non-regulated markets.
- Draft customer responses for global clients.
- Evaluate processes and routes of synthesis for drug substances.
- Compile and review regulatory submissions, STPs, change controls, AMV, impurity profiles, and characterization data.
- Prepare LOAs, CEP LOAs, declarations, and other regulatory reference documents.
- Verify current monographs during DMF filing to ensure compliance.
Desired Candidate Profile:
- Proficient in Regulatory Affairs documentation and DMF submissions.
- Knowledgeable in eCTD/CTD formats and global regulatory guidelines.
- Strong analytical, documentation, and problem-solving skills.
- Ability to manage multiple projects in a fast-paced environment.
Eligibility / Qualifications
- Education: B.Pharm, M.Pharm, or relevant life sciences degree.
- Experience: Minimum 3 years in Regulatory Affairs, preferably in API/Pharma industry.
- Skills Required:
- Regulatory submissions for USFDA, Health Canada, EDQM, and other global markets.
- Handling DMFs, EDQM submissions, process evaluation, and compliance documentation.
- Knowledge of global regulatory guidelines and eCTD/CTD standards.
Location & Salary
- Job Location: Dholka, Ahmedabad
- Salary: Competitive, based on experience and skill set
Application Process
Interested candidates can share their resumes at disha.bhalani@cadilapharma.com. Ensure your CV highlights:
- Regulatory submission experience
- DMF/EDQM handling
- Relevant industry exposure
Note: Immediate applications are encouraged as positions are limited.
Why Join Cadila Pharmaceuticals?
- Global Exposure: Work on submissions for regulated international markets.
- Career Growth: Enhance expertise in Regulatory Affairs, documentation, and compliance.
- Professional Environment: Collaborate with experienced regulatory scientists and analysts.
- Impactful Work: Contribute to the approval and compliance of critical pharmaceutical products worldwide.
FAQs
Q1: Is prior DMF submission experience mandatory?
A: Yes, candidates should have hands-on experience with DMF, EDQM, and regulatory documentation.
Q2: Can freshers apply?
A: No, minimum 3 years of experience in Regulatory Affairs is required.
Q3: Are global regulatory markets involved?
A: Yes, submissions are for US, Canada, China, Korea, and non-regulated markets.
Q4: What formats are used for submissions?
A: eCTD and CTD formats for regulatory submissions.
Summary Table
| Category | Details |
|---|---|
| Company | Cadila Pharmaceuticals Ltd. |
| Vacancies | Not specified (Immediate openings) |
| Required Education | B.Pharm, M.Pharm, Life Sciences Degree |
| Experience | Minimum 3 years in Regulatory Affairs |
