Manager-Regulatory Affairs (API & Formulations)

Hyderabad, India

India

Master in Pharmacy

Hyderabad, India

India

Master in Pharmacy

Profile attachments

Microsoft WindowsApplication Programming Interfaces (APIs)DOS (Disk Operating System)Microsoft OfficeOperational SystemsRegulatory Affairs

API (DMFs), Formulations (Dossiers), Packages, MS Office, Operating System, Windows, DOS, Pharmaready, Lorenz Docubridge, ISIS draw

Experience

Professional experience10+ years

Languages

EnglishFluent

Project history

Asst.Manager, Formulations & API-RA

AET Laboratories Pvt Ltd

Hetero Labs Limited (USFDA, EDQM, UK, TGA, Korea-MFDS Approved) Work Location at Hyderabad,
Telangana (as Sr. Executive, API-RA) February 2018 to August 2019

Asst.Manager, Formulations & API-RA

AET Laboratories Pvt Ltd

CORE COMPETENCIES (DRUG PRODUCT)

AET Laboratories Pvt Ltd (German based company-USFDA, EDQM, Russian Approved) Work Location at
Hyderabad, Telangana (Asst.Manager, Formulations & API-RA) August 2019 to till

* Working in the field of Formulation Regulatory affairs from 2 years
* Overall filed about 2 dossiers to various regulatory agencies (US, EU-Module-2 and Module-3)
and 10+ products LCM (Post approvals-API related changes/variations)
* DMFs and Query responses review received from various vendors (80+ API vendors)

* Well aware of current regulatory guidelines and compliance requirements for major regulatory
markets. Well aware of current GDUFA requirements for dossier, facility registration and other
activities.
* Preparation and review of quality CMC documentation for submission, assuring technical
congruency and regulatory compliance, meeting agreed timelines for US, EU, Canada, Australia
and New Zealand regions.
* Review and approve the documents like Specifications, Test Procedures, Stability protocols,
Validation protocols, Product development reports, Process validation protocols as per the
guidelines / Pharmacopoeia.
* Responsible for addressing queries / deficiency raised by US / European and other regulatory
authorities to support the approval process
* Involved during product development stages of projects for regulatory requirements to US and
European markets
* Supported corporate regulatory affairs, i.e. by review/collection of plant documents from
different departments (responsibility of plant regulatory affairs) during beginning of carrier

Executive, API-RA

Neuland Laboratories Ltd

Research Associate-4, API-RA

Laurus Labs Pvt Ltd

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)

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