Drug Regulatory Affairs

Job Title - Regulatory Affairs Experience - 3 -5 years in finished doses form Location - Pune Industry - Leading Pharma Industry Roles and Responsibilities To coordinate and preparation of Quality Agreements. Maintain the required documents for Regulatory Affairs. Liaising with customers and regulatory authorities regarding quality matters, including...

Regulatory affairs officers ensure that products such as foods, cosmetics, pharmaceuticals and veterinary medicines - and the steps involved in developing, testing and marketing them - meet legislative requirements. Typical duties include: - studying scientific and legal documents to check they meet legal requirements. - gathering, evaluating, organising,...

Job Title Regulatory Affairs Specialist Job title Regulatory Affairs Specialist Your role Be recognized as a key talent in International Regulatory filings and procedures Be considered a key regulatory point person in Centralization of Regulatory Operations and enable the regulatory compliance in Markets where Philips products are commercialized ...

Regulatory Affairs Specialist Job DescriptionRole Overview:The Regulatory Affairs Specialist plays a vital role in ensuring compliance with international regulatory guidelines and country-specific requirements by preparing, reviewing, and maintaining regulatory documents.This involves coordination with internal teams and external stakeholders to support...

_**Duties/Responsibilities**:_ - Works in the regulatory affairs department on assigned projects. - Coordinates with product development and/or research and development teams to request, develop, and prepare required data and reports to be submitted to regulatory bodies and agencies. - Collaborates with key staff from Planning, Product Development,...

**Job Description - Regulatory Affairs Executive** **Position**:Regulatory Affairs Executive **Location**:Pune, India **Experience**:2 - 5 Years **Market Focus**:Emerging Markets (LATAM and Middle East) **Qualification**:B. Pharm, M. Pharm, Microbiology, or relevant degree **Roles & Responsibilities**: - Regulatory Documentation & Submission &...

Regulatory Affairs SpecialistWe are seeking a detail-oriented professional to support end-to-end submissions for global markets.Responsibilities:Evaluate post-approval changes in compliance with global regulatory requirements.Contribute to Lifecycle Management activities by helping to compile and review dossier modules.Compile initial dossiers for various...

Job Title: Sr. Regulatory SpecialistLocation: Pune/BangaloreExperience:5-8YearsJob Description:As the Sr. Regulatory Specialist, this position will:Must Have:(SaMD product experience)Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for...

Job Title: Regulatory Compliance Specialist Job Description Our organization is seeking a skilled regulatory compliance specialist to oversee the management of pharmaceutical and biological documentation, as well as registration applications for chemical active substances and biological medicinal products. The successful candidate will be responsible for...

JOB DETAILS Manage Pharmaceutical and biological documentation & Registration application for chemical active substances, biological medicinal products & data control activitiesSchedule as per Drugs and Cosmetics Act, India GMP and USFDA CGMP Maintain Cell Therapy guidelines, USFDA guidelines, EMA Animal Safety & efficacy studies with GLP certified...