NewLife Medicals, a trusted name in pharmaceutical sourcing and regulatory solutions, is hiring a Senior Executive Regulatory Affairs to join our team in Mumbai, Maharashtra. With a mission to be Your Trusted Lifeline, we specialize in supplying Reference Drugs, Orphan Drugs, APIs, and medical equipment globally, serving clients in over 50 countries.
If you have expertise in regulatory affairs for CIS, LATAM, and Africa markets, join us to ensure compliance and drive our international operations forward in the pharmaceutical industry.
Application Details
- Location: Mumbai, Maharashtra, India
- Application Method: Email your updated CV to hr@newlifemedicals.com with the subject line “Senior Executive Regulatory Affairs – Mumbai”
- Application Deadline: May 15, 2025
- Contact Email: hr@newlifemedicals.com
- Website: www.newlifemedicals.com
Notes:
- Candidates must submit an updated CV, academic certificates, experience letters, and last 3 months’ payslips.
- Include total experience, current CTC, expected CTC, and notice period in your application.
- Immediate joiners are preferred.
- Fraud Alert: NewLife Medicals does not charge recruitment fees. Verify opportunities via www.newlifemedicals.com.
Why Join NewLife Medicals?
Since 2018, NewLife Medicals has emerged as a reliable pharma raw material supplier and medical equipment provider in India, praised by industry leaders like Cipla and Zydus for timely delivery and cost-efficient solutions.
With a focus on regulatory excellence, we streamline complex registrations for clients, saving up to 30% on procurement costs, as noted by Cadila Healthcare. Rated 4.0/5 for work culture on Glassdoor based on 50+ reviews, our Mumbai office offers a collaborative environment and competitive salaries (₹6–9 Lakhs per annum for similar roles). Join us to work on high-impact regulatory projects for CIS, LATAM, and Africa markets.
Job Position: Senior Executive Regulatory Affairs
We are seeking a skilled professional to manage regulatory compliance and dossier preparation for our global pharmaceutical exports.
Job Details
- Qualification: M.Pharm in Regulatory Affairs
- Experience: 3–5 years in pharma exports
- Location: Mumbai, Maharashtra
- Employment Type: Full-time, Office-based
Key Responsibilities
Dossier and Document Management
- Prepare and submit regulatory dossiers for product registrations in CIS (e.g., Russia, Ukraine), LATAM (e.g., Brazil, Mexico), and Africa (e.g., Nigeria, South Africa) markets
- Review and compile documents, including CTD/eCTD modules, per ICH guidelines and regional requirements (e.g., SAHPRA, COFEPRIS, ANVISA)
- Ensure compliance with import, export, and marketing authorization regulations
Coordination and Liaison
- Coordinate with international regulatory bodies, partners, and distributors to facilitate approvals
- Act as a liaison for regulatory submissions, addressing queries and ensuring timely responses
- Collaborate with R&D, QA, and production teams to align documentation with product development
Compliance and Monitoring
- Monitor regulatory changes and guidelines in CIS, LATAM, and Africa markets, updating internal processes accordingly
- Maintain product compliance with global standards, including GMP and WHO requirements
- Manage documentation databases, ensuring accuracy and accessibility for audits
Required Skills and Qualifications
| Category | Details |
|---|---|
| Education | M.Pharm in Regulatory Affairs |
| Experience | 3–5 years in pharma exports, preferably with CIS, LATAM, Africa markets |
| Technical Skills | Knowledge of ICH, SAHPRA, ANVISA, COFEPRIS, and eCTD submission processes |
| Regulatory Knowledge | Familiarity with CIS (Russia, Ukraine), LATAM (Brazil, Mexico), and Africa (Nigeria, South Africa) norms |
| Soft Skills | Strong communication, coordination, and analytical skills |
| Tools | Proficiency in MS Office, regulatory databases, and eCTD software |
Why This Role?
- Global Impact: Drive regulatory compliance for products reaching 50+ countries, enhancing patient access to critical drugs.
- Career Growth: Gain expertise in emerging markets, with a 4.1/5 rating for skill development at NewLife Medicals.
- Dynamic Environment: Work in Mumbai, India’s pharma hub, with exposure to diverse regulatory frameworks.
- Trusted Employer: Join a company lauded for “streamlining complex registrations” by Zydus Healthcare.
How to Apply
To apply for the Senior Executive Regulatory Affairs position, follow these steps:
- Prepare Your Documents: Update your CV, highlighting your M.Pharm and 3–5 years of export experience, and gather academic certificates, experience letters, and payslips (last 3 months).
- Email Your Application: Send your documents to hr@newlifemedicals.com with the subject “Senior Executive Regulatory Affairs – Mumbai.”
- Include Key Details: Mention your total experience, current CTC, expected CTC, and notice period.
- Research NewLife Medicals: Visit www.newlifemedicals.com to understand our sourcing and regulatory expertise.
- Prepare for the Interview: Be ready to discuss dossier preparation, CIS/LATAM/Africa regulations, or eCTD submissions.
Verified by Trusted HRs
The post is released by the NewLife Medicals LinkedIn page. Click here to visit the post
Why Mumbai, Maharashtra?
Mumbai, India’s pharmaceutical and financial capital, hosts over 500 pharma companies, making it a global hub for regulatory affairs. NewLife Medicals’ office in Mumbai offers a modern workspace and access to a vibrant industry network. With excellent connectivity and a thriving job market, Mumbai is ideal for career growth in life sciences. Learn more about Mumbai’s pharma sector.
Contact Information
For inquiries or to apply, reach out to:
- Email: hr@newlifemedicals.com
- Office Address: NewLife Medicals, Mumbai (Exact address shared upon application confirmation)
- Website: www.newlifemedicals.com
- LinkedIn: NewLife Medicals
Don’t miss this chance to join NewLife Medicals and shape the future of global healthcare compliance. Apply by May 15, 2025, and become part of our mission to be Your Trusted Lifeline!