Metrochem API Pvt Ltd was established by Dr. N.V. Rao in the year 2004, with a grand vision of being the most preferred supply partner to pharmaceutical customers worldwide. The management aimed to achieve this vision with a clear focus on quality, affordability and products at Metrochem API Private Limited is one of the fastest growing manufacturers of Active Pharmaceutical Ingredients (APIs), Pellets (Semi finished Formulations) and Intermediates.
Greetings from Metrochem API…!
We are hiring Assistant Manager- API – Regulatory Affairs
Interested candidates can share their CV to firstname.lastname@example.org or call to 8187888831.
Job Description for RA (API) role:
1. Examining the conformity of all documents for approval must be compliant to all relevant regulations, rules and standards and taking part in the conformity assessment procedure with coordination of all concerned departments.
2. Developed and maintained an in dept , ongoing knowledge of Guidelines, Regulations, Directives and requirements for submission.
3. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly and support the relevant departments in fulfilling the regulatory requirements
4. Handling of Authority and Customer Queries.
5. DMF or Dossier Preparations and submission.
6. Providing the regulatory strategic note for building the product by exploring various literature and summary basis of approval provided by various regulatory authorities.
7. To provide the regulatory in-puts for the change controls assigned.
8. Make sure the proper regulatory data base maintenance.
9. Building the regulatory awareness.
10.Genotoxic impurities assessment and control strategy.
Candidate desired skills:
Master’s degree in Organic Chemistry is required
Experience of 7-10 years in API RA
Work Location: R&D Centre, Shapurnagar, Hyderabad
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