Regulatory Affairs Executive

**Executive Regulatory Affairs (API Pharma)** **Qualification**: M.Sc. - Organic & preferably diploma or must have worked in Regulatory Affairs department of Pharmaceutical Organization / API **Experience** : 8 - 10 years in Quality Assurance department (QA) of Pharmaceutical Industry & regulatory Affairs department ,preferably from API Pharma industry. -...

**Department**: Regulatory Affairs **Designation**: Executive **Education / Qualification**: B. Pharm **Experience**: 3 to 5 year **Salary**: As per company Standards **Responsibilities**: - Data compilation, Preparation of DCP, EDMF, CEP, and Drug Master File (DMF)/Formulation Dossier related to other countries as per marketing department requirement...

Regulatory Executive (Female)/ Dombivli - Mumbai Pharmaceutical Thane, Dombivli Share VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing...

As a regulatory affairs officer, you'll need to: - ensure that a company's products comply with the regulations of the regions where they want to distribute them - keep up to date with national and international legislation, guidelines and customer practices - respond to queries from medical bodies like Healthcare products Regulatory Agency (MHRA) -...

**Department**: Regulatory Affairs **Designation**: RA - Officer **Education / Qualification** : B. Pharm **Experience**: 0 to 1 year **Salary**: As per company Standards **Responsibilities**: - Registering our manufacturing site in Sedex platform, completing Responsible Sourcing Policy and initiating for Smeta 4 pillar Audit from 3rd party Audit...

Handling dossier, COPP submission and query Handling for South East Asian Country, East Africa, Latin America, Central America, Europe. - In depth knowledge about regulatory requirements for above region - Need to work independently - Need to have knowledge about legal documents requirement and it’s processing. - New customer development and new business...

Review and interpret applicable regulations and guidelines - Manage and ensure the accuracy of regulatory documents - Monitor and respond to changes in the regulatory environment - Develop and maintain strong working relationships with relevant stakeholders - Participate in internal and external audits - Keep up to date with developments in the regulatory...

We are looking for young and enthusiastic minds, who will be responsible for the following roles - 1. Preparation and compilation of CTD and ACTD dossiers for Vietnam, Myanmar and ROW market 2. Review of Process Validation, Analytical Method Validation, Product Development Records, BMR, BPR, Stability data, Certificate of Analysis etc. required for...

Job description Designation title / Role title **Trainee - Regulatory Affairs & Sourcing** Department -Regulatory Affairs Band - Junior level Business Unit - Maxima Solutions Overall Role Purpose - Assisting in regulatory affairs and sourcing for complete organization. Reports to - Executive - Regulatory Affairs & Sourcing Scope of Role Mention Key...

Preparation of dossier sections for EU/Australia/Canada/Emerging market. - Variation filing in above markets - Artwork management - Review of analytical documents - Review of QMS documents