Key Responsibilities
CORE COMPETENCIES (DRUG SUBSTANCE)
* Working in the field of API Regulatory affairs for more than 8 years
* Overall filed around 25+ DMF to various regulatory agencies (US, Canada, EU, and Brazil and
Mexico)
* Currently handling regulatory submissions (new and amendments), deficiencies and customer
support for two manufacturing facilities (more than 120 DMFs).
* Regulatory strategic planning and submission a post approval changes to various regulatory
agencies to get timely approvals.
* Supporting business development team to meet customer requirement
* Well aware of nitrosamines requirement in drug substance and dosage forms for regulatory
markets (US, EU, TPD and others LATAM)
* Submission of DMF to markets like US, EU, Canada, TGA, LATAM (Brazil and Mexico), and other
international markets, that conforms to both CTD and regional requirements for all related
registration activities (Module-1, Module-2 and Module-3)
* Complying to GDUFA requirements for facility registration and other activities.
* eCTD submissions (Pharmaready, Lorenz Docubridge and CESP gateway).
* Selection of starting materials and setting of specifications during process development
* Review of data of API viz. laboratory development report, process package and all relevant
technical data required for DMF filing in USA, Europe and other countries.
* Addressing queries / deficiency raised by regulatory authorities to support the approval
process
* Review and submission of post approval changes to Europe, EDQM, US many other countries viz.
annual updates, supplements and variation notification to the customers/ Agencies.
* Obtaining the license to manufacture drug substance and drug products (Form-25, Form-29,
export NOC etc...), EU Written Confirmation application to CDSCO and submission of Nutraceutical
applications to FSSAI
* Review of the specification and test procedures of raw materials and finished products,
general procedures, certificate of analysis, stability protocol and stability data.
* Active participation during regulatory audits like USFDA, Brazil (ANVISA), Europe (Germany)