The Role
Manage regulatory documentation and dossiers across Modules 1–5 for new product registrations and renewals in emerging markets. Prepare, review, file, and submit technical dossiers while coordinating with cross-functional teams. Ensure regulatory compliance, product registration, lifecycle management, stakeholder coordination, and effective communication.
Summary Generated by Built In
- Position: Executive/ Sr. Executive - Regulatory Affairs
- Market: Emerging markets (Africa, Asia, CIS, Brazil, Mexico)
- Job Location: Corporate Office, Ahmedabad
- Experience required: 3 – 6 Years
- Qualification: ,M.Pharm/ B.Pharm/ M.Sc
Job Summary:
- > Documentation for M1, M2, M3, M4 and M5
- > Preparation of Dossier for new registration
- > Preparation of Dossier for renewal
- > Dossier filling and submission
- > Co-ordinate with CFT
Required Skills:
> Must have experience in documentation part of all modules (M1 to M5)
> Regulatory Compliance Management
> Product Registration & Lifecycle Management
> Cross-Functional Stakeholder Management
> Technical Dossier Review & Submission Management
> Good communication
About the company profile:
Kindly go through our official website www.coronaremedies.com
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Warm regards,
Yashh Bharucha
Assistant Manager - Corporate HR
CORONA Remedies Limited
LinkedIn: https://www.linkedin.com/in/yashh-bharucha-a92a7555/
Skills Required
- 3–6 years of regulatory affairs experience
- M.Pharm, B.Pharm, or M.Sc. qualification
- Experience documenting all regulatory dossier modules M1–M5
- Regulatory compliance management experience
- Product registration and lifecycle management experience
- Cross-functional stakeholder management experience
- Technical dossier review and submission management experience
- Good communication skills
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The Company
What We Do
CORONA Remedies Limited is an Ahmedabad-based pharmaceutical company founded in 2004. It develops, manufactures, and commercialises innovative, value-added, evidence-based medicines addressing unmet health needs. Its portfolio focuses on chronic-care and specialty therapeutic areas, including women’s healthcare and pain management. The company operates manufacturing facilities in Gujarat and Himachal Pradesh and aims to improve health outcomes through quality products and research.
