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:
- Responsible for submissions and Lifecycle Management - Europe/UK/US/Canada/WHO
and ROW market.
- Preparing Nitrosamine Risk Assessment Report for Sartans and other drug substances.
- Submissions of USDMF, EU-ASMF, CEP, WHO and Health Canada query responses to
the respective regulatory authorities through electronic submissions. (ESG, CESP
submissions)
- Submission of US-Amendments/ASMF Updates/CEP Revisions adequately based on
changes proposed for the drug Substances.
- Notifications of US-Amendment/ASMF Update/CEP Revision to relevant customers.
- Preparing and compiling DMF/Technical Packages & Dossiers for submission to the
Regulatory Agencies of the various countries (US, Europe, WHO, Canada & ROW).
- Knowledge and experience in preparation & reviewing of Module 1 to Module 3 CMC
Documentation. Compiling eCTD sequences through Pharmaready.
- Review of Validation reports, Stability studies, Specifications/ Method of Analysis, Batch
Manufacturing Records (BMR’s/MFR’s), Pharmaceutical Development Reports (PDR).
- Interact with various departments/teams for regulatory documents and compilation on time
as per regulatory requirements.
- Maintenance of the complete history of each drug substance (Filing history with
agencies/customers, deficiency responses, amendments, annual reports)
- Issue Letter of Access and other relevant regulatory documents and their submission to
regulatory authorities.
- Review of all documents from QA, R&D, AR&D, Production and other department with
respect to correctness and compliance for regulatory submission.
- 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.
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Titan Laboratories Pvt Ltd Recruitment - Job vacancies[/caption]
https://pharmastuff.org.in/job/titan-laboratories-regulatory-affairs-api-navi-mumbai
