10 Job openings found

The job description is as below: Purpose of the RoleTo ensure timely, accurate, compliant, and scientifically justified responses to regulatory and customer queries related to pharmaceutical and medical device testing, in alignment with global regulatory and accreditation requirements. Key Responsibilities 1. Regulatory Query ManagementReceive, log, track, and respond to regulatory queries, including US ...

Job responsivities are to assist Regulatory manager Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD, ACTD as well as country specific format for countries Preparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbal products for country specific format in countries of African Region, Cambodia, Myanmar, ...

Job responsibilities are to Assist Regulatory manager: Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD, ACTD as well as country specific format for countries Preparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbal products for country specific format in countries of African Region, Cambodia, Myanmar, CIS To manage ...

Job responsibilities : Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD, ACTD as well as country specific format for countries Preparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbal products for country specific format in countries of African Region, Cambodia, Myanmar, CIS To manage new registration / preregistration ...

  Job responsibilities:Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD,ACTD as well as country specific format for countriesPreparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbalproducts for country specific format in countries of African Region, Cambodia, Myanmar, CISTo manage new registration / preregistration / ...

Job Summary The Regulatory Affairs Manager is responsible for ensuring that products are in compliance with all applicable regulations and laws. This includes developing regulatory strategies, preparing regulatory submissions. The Manager also provides guidance to the cross functional and Area regulatory affairs team and ensures that all regulatory activities are aligned ...

The job description is as below: Conduct Research: Perform extensive primary and secondary research using online databases, internal records, and open media to locate relevant information. Analyze Data: Filter and interpret complex data sets, research findings, and market-related information to draw meaningful conclusions in response to client or internal queries. Formulate Responses: Develop clear, concise, and ...

Job Description   -Compilation and submission of eCTD dossier for new product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US) -Hand on experience in preparation of CTD section as per regulatory requirements of different region -Having experience in preparation of query response and PAS, CBE and annual report. -Have ability to co-ordinate with ...

  Job Description Heading the regulatory department of the company and leading a team of executives/Senior executives/Asst.Manager.- Must be aware of the latest country specific guidelines for ROW market and capable of planning and implementing,guiding, supporting, reviewing and finally approving the dossiers and implementing the other defined activities of thedepartment.- Coordination with ...

Dossier preparation as per the ACTD & CTD (Module I, II, III, IV and V) guideline. Technical documents like Raw Material and finished products specification, manufacturing process, Product development report, stability reports, process validations preparation & review. Analytical method validation review as per the ICH guideline. Drug Master File review Technical query response to the ...