Metrochem API Hiring For Assistant Manager- API - Regulatory Affairs
We are hiring Assistant Manager- API - Regulatory Affairs
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
Interested candidates can share their CV to sirisharani.mallisetti@metroapi.com 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.
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