Encube Ethicals hiring for Regulatory Affairs department || Marol (Andheri), Mumbai

Encube Ethicals hiring for Regulatory Affairs department || Marol (Andheri), Mumbai

We at Encube are hiring for Regulatory Affairs department.

Qualification: M.Pharm (preferably in Regulatory Affairs/ Chemistry/Pharmaceutics)

Experience: 7-12 years

Location: Marol (Andheri), Mumbai.

Role & responsibilities

1. Dossier compilation of initial MAA for Europe Market.
2. Response to EU authorities deficiency.
3. Scientific Advice.
4. Variations and Supplements (Type IA, IA, Type IB Type.
5. Timely review of technical and regulatory documents i.e. Specifications, batch records, method validation documents, Stability data, container closure system, DMF review.
6. Hands on Electronic Operation (eCTD).
7. Experience in E Submission Gateway.

Skill Requirements

1. Min 5 years experience in Europe submission via DCP/ MRP or National.
2. Experience in addressing the EU authority deficiencies satisfactorily.
3. Understanding and knowledge about presentation of data in Scientific advise from EU Agencies such as BfArM. Thorough knowledge of EU Variations in EU
4. Knowledge of the review of CMC/Clinical/Regulatory documentation required for submission.
5. Working capabilitles preferably on PharmaReady or equivalent software.

6. Working capabilities on CESP Portal preferred.

Interested Candidates can share their resume on [email protected]