Titan Laboratories Hiring Regulatory Affairs API Officer/Sr. Officer/Executive/Sr. Executive/Asst. Manager

Titan Laboratories Hiring for Regulatory Affairs API in Navi Mumbai

Join Titan Laboratories Pvt Ltd as a Regulatory Affairs API Professional

Titan Laboratories Pvt Ltd, a leader in pharmaceutical manufacturing, is seeking experienced professionals for the position of Regulatory Affairs API at their Navi Mumbai (Turbhe) Head Office. If you have 9+ years of experience in regulatory submissions and lifecycle management, this is an excellent opportunity to advance your career.

Job Responsibilities

As an Officer/Sr. Officer/Executive/Sr. Executive/Asst. Manager in Regulatory Affairs API, you will be responsible for:

1. Responsible for submissions and Lifecycle Management – Europe/UK/US/Canada/WHO
   and ROW market.
2. Preparing Nitrosamine Risk Assessment Report for Sartans and other drug substances.
3. Submissions of USDMF, EU-ASMF, CEP, WHO and Health Canada query responses to
   the respective regulatory authorities through electronic submissions. (ESG, CESP
   submissions)
4. Submission of US-Amendments/ASMF Updates/CEP Revisions adequately based on
   changes proposed for the drug Substances.
5. Notifications of US-Amendment/ASMF Update/CEP Revision to relevant customers.
6.  Preparing and compiling DMF/Technical Packages & Dossiers for submission to the
   Regulatory Agencies of the various countries (US, Europe, WHO, Canada & ROW).
7. Knowledge and experience in preparation & reviewing of Module 1 to Module 3 CMC
   Documentation. Compiling eCTD sequences through Pharmaready.
8. Review of Validation reports, Stability studies, Specifications/ Method of Analysis, Batch
   Manufacturing Records (BMR’s/MFR’s), Pharmaceutical Development Reports (PDR).
9. Interact with various departments/teams for regulatory documents and compilation on time
   as per regulatory requirements.
10. Maintenance of the complete history of each drug substance (Filing history with
    agencies/customers, deficiency responses, amendments, annual reports)
11.  Issue Letter of Access and other relevant regulatory documents and their submission to
    regulatory authorities.
12.  Review of all documents from QA, R&D, AR&D, Production and other department with
    respect to correctness and compliance for regulatory submission.
13. Audit Faced: WHO-GENEVA, USFDA, EDQM and Customer audits.

Qualifications

• Experience: 9+ years in Regulatory Affairs API.
• Educational Background: M. Pharma or B. Pharma.
• Location: Navi Mumbai (Turbhe) Head Office.

How to Apply

Interested candidates can share their resumes with Shweta M at shweta.m@titanpharma.com.