Location: Ahmedabad Corporate Office
Position Overview:
Big Pharma is seeking a talented and experienced individual for the role of AM / DM in Regulatory Affairs (API) focused on the US Market (DMF Filing). This role is essential for our corporate team and requires specific expertise in regulatory affairs for APIs.
Key Responsibilities:
- Conduct technical reviews of API DMFs for the US market.
- Prepare ANDA Drug Substance Modules and respond to deficiencies.
- Review API Nitrosamine Risk Assessment Reports.
- Utilize strong technical writing, communication, and presentation skills.
Requirements:
- Current Designation: Senior Executive (minimum 2 years) or Assistant Manager and above.
- Must have experience in corporate regulatory affairs. Plant RA experience is not required.
- Proven experience in regulatory affairs for APIs.
How to Apply:
Interested candidates are invited to share their CV via email or WhatsApp.
- Email: swati.bigideashr@gmail.com
- WhatsApp: 9871855807