Regulatory Affairs Executive

2 days ago

Hyderabad, India MakroCare Full time

MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion.

MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS), ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)

**We have two positions for our RA Deportment**

**Job Description for the below roles**:
**1) Regulatory Affairs Executive & **2) Regulatory Affairs Associate**

1. Preparation, Review and submission of Technical documents/Dossiers (CTD/ACTD) for Regulatory and Non Regulatory Markets.

2. Publishing electronic regulatory submissions (eCTD):
Submission build activities, creating inter-document links, performing a quality checks and validating compiled submissions, and finalizing submission by the required dispatch date.

3. Coordination with the team for timely submissions.

4. Reviewing manufacturing documents like MFC, BMR, process validation Protocol/report, stability protocol/report, sampling protocol, process validation protocol and PDR.

5. Preparation and review of the response to the Agency's queries and submission within the stipulated time given by health authorities.

6. To develop and deliver complete regulatory submissions within agreed timeframes. Providing regulatory support to project teams for assigned projects.

**Requirements**:
A minimum of **1 - 4** years of experience with **eCTD** and **Publishing** in Regulatory - CRO or Biopharma industry side.

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