Alchem International Private Limited Recruitment 2023.Alchem International Private Limited Notification full detailes below.The Company was founded in 1935. Alchem International Pvt. Ltd. is a pioneer in the field of Phytochemicals with over 80 years of experience in providing plant derived active ingredients to the Pharmaceutical, Cosmetic and Nutraceutical industries across 35 countries globally.
Important Vacancy details:
- Post Name: Regulatory Affairs (API)
- Education: B.Pharma in Any Specialization/MS/M.Sc(Science) in Chemistry, M.Pharma in Any Specialization
- Experienced:5 to 10 years
- Location: Faridabad,Haryana
Important Details :
- Post of date:19/10/2023
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to Face
- Interview Rounds of Interview: HR
Roles and Responsibilities
Documents review, compilation of DMFs for filing to Regulated markets such as US, Europe, Canada and other emerging markets.
Filing Annual updates and Amendments to various regulatory agencies related to submitted DMFs.
Well versed in filing of DMFs in eCTD, CTD and others related formats as per countries specific requirements.
Handling queries obtained from different regulatory agencies and customers.
Circulate checklist for query & other requirements and compile query response.
Compliance to audits of regulatory bodies especially USFDA and EU.
Coordination and generation of documents from R&D, Production, QC, QA and others stakeholders as per requirement.
Lead the trainings program/calendar for ICH guidelines and regulatory updates to employees periodically.
Responsible for record keeping and to ensure correctness of records pertaining to department
If interested send me your update resume with salary details at:
[email protected] or [email protected]