Job Details

Regulatory Affairs (API)Jobs in SynZeal Research Private Limited - Ahmedabad, Gujarat

SynZeal Research Private Limited

Ahmedabad, Gujarat, India

2-5 years

Full Time

25 weeks ago25 weeks ago

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Job Description

Job Title: Regulatory Affairs (API)
Qualification: MPharm/MSc
Location: SynZeal Research Private Limited - Ahmedabad, Gujarat
Work Experience: 2 to 5 Years

Job Description

Prepare and submit regulatory documents for API (Active Pharmaceutical Ingredient) as per global guidelines.
Compile and review DMF (Drug Master File) for USFDA, EU, and other markets.
Coordinate with R&D, QA, QC, and Production for regulatory documentation.
Handle deficiency letters, queries, and regulatory responses.
Ensure compliance with ICH, USFDA, EDQM, WHO guidelines.
Maintain product registration dossiers and variation filings.
Track regulatory updates and implement changes accordingly.
Support regulatory audits and inspections.

Take this opportunity to join SynZeal Research Private Limited - Ahmedabad, Gujarat as a Regulatory Affairs (API) in Ahmedabad, Gujarat and build a successful career in the healthcare industry. Apply today for this job opportunity and grow with a leading healthcare organization.

Preferred Education

MPharm (Master Of Pharmacy)
MSc Chemistry

Key Skills

Analytical SkillsAttention to DetailDocumentation

Aggregated job

Job Details

Regulatory Affairs (API)Jobs in SynZeal Research Private Limited - Ahmedabad, Gujarat

SynZeal Research Private Limited

Ahmedabad, Gujarat, India

2-5 years

Full Time

25 weeks ago25 weeks ago

Upload Resume to Apply Faster

Quick apply to this and other jobs with one click

Job Description

Job Title: Regulatory Affairs (API)
Qualification: MPharm/MSc
Location: SynZeal Research Private Limited - Ahmedabad, Gujarat
Work Experience: 2 to 5 Years

Job Description

Prepare and submit regulatory documents for API (Active Pharmaceutical Ingredient) as per global guidelines.
Compile and review DMF (Drug Master File) for USFDA, EU, and other markets.
Coordinate with R&D, QA, QC, and Production for regulatory documentation.
Handle deficiency letters, queries, and regulatory responses.
Ensure compliance with ICH, USFDA, EDQM, WHO guidelines.
Maintain product registration dossiers and variation filings.
Track regulatory updates and implement changes accordingly.
Support regulatory audits and inspections.

Take this opportunity to join SynZeal Research Private Limited - Ahmedabad, Gujarat as a Regulatory Affairs (API) in Ahmedabad, Gujarat and build a successful career in the healthcare industry. Apply today for this job opportunity and grow with a leading healthcare organization.

Preferred Education

MPharm (Master Of Pharmacy)
MSc Chemistry

Key Skills

Analytical SkillsAttention to DetailDocumentation

Aggregated job

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Job role:

Regulatory Affairs Executive

Job category: Pharmaceuticals

SynZeal Research Private Limited

SynZeal Research Private Limited is an organization focused on providing pharmaceutical development and contract research services, including API development, formulation support, and analytical testing. The company follows Good Manufacturing Practices (GMP), quality assurance protocols, and regulatory compliance to ensure reliable research and manufacturing support. Procurement roles involve sourcing active pharmaceutical ingredients (APIs), negotiating with suppliers, managing vendor relationships, and ensuring timely availability of quality materials. It emphasizes cost efficiency, documentation accuracy, compliance with quality standards, and coordination with technical and quality teams. SynZeal Research Private Limited is committed to supporting pharmaceutical research and development with robust operational and quality systems.

About DoctHub Jobs - Healthcare Jobs Portal

Docthub Jobs is a dedicated healthcare job portal to find the latest healthcare jobs in India, including medical coding jobs, nursing jobs, and hospital vacancies. Discover opportunities for freshers and experienced professionals with smart filters and real-time updates. Docthub provides a option so recruiters can directly connect with you. Our platform also offers to help you showcase your availability to recruiters and a Resume Builder to create a professional resume in minutes. Explore jobs across top cities and apply to verified openings with ease.