Essenzaa Nutrition Pvt Ltd Recruitment Notification for Regulatory affairs associate at Mumbai, Maharashtra, India.
Industry: Supplements Manufacturer, Ayurveda,Nutraceutical
Designation: Regulatory Affairs Executive
Employment type: Permanent
Education: Bsc, Msc, B Pharm, M Pharm, MBA (Regulatory Affairs)
Experience: 2-3 years
Roles & Responsibilities:
- Responsible for Dossier compilation:
a. To prepare New, Renewal dossier and variations (Site/ Formula) for countries and having specific Regulatory knowledge of Guidelines viz, ICH, FDA PICS etc.
b. To review accuracy of executed data before submission – Plant generated validation reports and raw data as required to ensure compliance before Dossier submission.
c. To review of documents for adequacy and accuracy.
d. To ensure regulatory compliance and liaison with countries / regulatory authorities during the product registration process.
e. To arrange the samples as per country requirements.
- Ensure timely delivery of regulatory query:
a. To review and ensure accuracy of deficiency response for Quality, Clinical part of dossier.
b. To evaluate the query received for registered or under registration products and Tender products and also to support for completion of the same in timely manner.
3. Other activities:
a. To maintain Data Bank for Commercial activity.
b. To work with quality standards and adherence to system.
c. To support marketing division with technical presentations and literature
d. To support corporate clients with published clinical studies, formulation, evidences, compilation of technical reference data.
e. Formulation and Development support.
f. Artwork Approval in compliance with local regulations.
- Compliance (Audits / Audit Readiness):
a. Support in Site Audit Readiness and Compliance relevant to RA functions / procedures based on external / internal audits.
b. To Audit Essenzaa sites to verify the executed documents (Process validation Protocol and reports and BMRs/BPRS) and its accuracy and readiness as per GDP and GMP norms.
c. Support factory staff in audits like HACCP, ISO 22000, HALAL, WHO-GMP, USFDA
5. Product License / Permission:
a. Liaison with the local regulatory bodies (FDA, FSSAI, Legal Metrology, DGFT, etc) and ensure all products manufactured are approved and within the permissible guidelines.
b. Apply for product permissions, FSC, etc and get them approved
Application Process : interested & Eligible Candidates please forward your updated cv on firstname.lastname@example.org
Location: Mumbai Salary: Industry Standard (2,40,000 – 3,00,000 PA)