Pharmazone Hiring Regulatory Affairs Assistant Manager, Executive

Pharmazone, a leading pharma services company, is looking to expand its Regulatory Affairs Team in Ahmedabad. We are currently hiring for Assistant Manager and Executive roles. If you have experience in regulatory submissions for the EU, US, and Asian markets, this is the perfect opportunity to advance your career.

Location: Ahmedabad, India
Positions Available: Assistant Manager, Regulatory Affairs Executive
Application Deadline: Open until filled

About Pharmazone

Established in 2009, Pharmazone has earned a reputation for excellence in pharma services. Over the past 15 years, we’ve grown into a team of over 100 skilled professionals, providing regulatory and clinical research services globally. Our dedication to quality and innovation has earned us several awards, including recognition as one of the Top 10 Clinical Research Service Providers by Silicon India in 2018. We were also named the Best Healthcare Brand in Gujarat by CMO Asia and ABP News.

Job Details

1. Assistant Manager, Regulatory Affairs

Key Responsibilities:

• Lead the preparation and submission of regulatory dossiers for EU and US markets.
• Oversee CMC documentation, including Module 1 and Module 5, as per eCTD guidelines.
• Coordinate with internal teams to ensure timely submission of documents.
• Review and provide input on regulatory strategy for product filings.
• Stay updated with changing regulatory guidelines in international markets.

Qualifications:

• Education: M. Pharm or MSc in relevant fields.
• Experience: 5-8 years in regulatory affairs with a focus on the EU and US markets.
• Proficiency in preparing and submitting dossiers in eCTD format.
• Strong understanding of regulatory guidelines, particularly related to CMC and Module 1 submissions.

2. Executive, Regulatory Affairs

Key Responsibilities:

• Assist in the preparation of regulatory submissions for EU, Asian, MEENA, and LATAM markets.
• Prepare and review eCTD and CTD dossiers for regulatory filings.
• Coordinate with external regulatory bodies to ensure timely submission of documents.
• Maintain up-to-date knowledge of regional regulatory requirements and compliance.

Qualifications:

• Education: M. Pharm or MSc in relevant fields.
• Experience: 1-3 years in regulatory affairs with experience in EU markets.
• Strong knowledge of eCTD and CTD formats.
• Familiarity with filing procedures in the Asian, MEENA, and LATAM markets.

How to Apply

Interested candidates can send their resumes to hr@pharmazones.com. For any inquiries, feel free to contact us at +91 98987 78211.