47 Job openings found

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 ...

Designation: Asst Manager Global Regulatory Affairs CMC (On a Contract ) Department: Global Regulatory Affairs CMC Contract Duration: 12 Months will be working on Talisman payroll (Not renewable) Location: MIDC Andheri East, Mumbai. Working Day: Monday To Friday Time: 9 A.M To 6 P.M   Primary Job Function: 1. Product registrations / Submissions-Assists in product registrations by preparing/ ...

    Regulatory Affairs Officer (RA) Qualification: B.Pharm/ M.Pharm Experience: Minimum 3 years in regulatory affairs for the ROW (Rest of the World) market, with a total of 3 to 5 years of experience. Job Description: Preparing dossiers as per country-specific guidelines. Compiling and reviewing documents. Coordinating with QA for documentation. Addressing queries raised by respective countries' FDA. Bond: 18-month ...

JD For QARA                                                Regulatory Compliance: Stay updated on medical device regulations, standards, and guidelines (e.g., FDA, ISO, CE Marking).  Ensure that products meet all regulatory requirements and maintain relevant documentation. Quality Assurance:  Develop and implement quality assurance processes and procedures. Conduct internal audits and assessments to identify areas for improvement. Collaborate with ...

Job Description:  Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. ? Preparation, Compilation & Review of Registration documents that include Administrative & Technical. ? Reviewing the technical documents provided by QA, QC, Production providing them the report of shortcomings & ...

works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products. They must have excellent organizational, analytical, project management, and communication skills. They work frequently with other employees and team members to coordinate complex activities, often with competing priorities. Most regulatory affairs positions ...

Description : Regulatory Compliance: Stay updated on medical device regulations, standards, and guidelines (e.g., FDA, ISO, CE Marking). Ensure that products meet all regulatory requirements and maintain relevant documentation. Quality Assurance: Develop and implement quality assurance processes and procedures. Conduct internal audits and assessments to identify areas for improvement. Collaborate with production teams to establish quality control ...

POSITION TITLE: Senior QA/RA SpecialistJOB LOCATION: Bangalore,IndiaDEPARTMENT: Quality & RegulatoryREQUIRED EDUCATION: Bachelor’s degree in biomedical engineering discipline or equivalent engineering degreeKEY RESPONSIBILITIES: ➢ Product QA/RA: • Provide quality and regulatory affairs input to the productdevelopment team and handle all QA & RA responsibilitiesthroughout product development, design change and post marketsurveillance process• As ...

works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products. They must have excellent organizational, analytical, project management, and communication skills. They work frequently with other employees and team members to coordinate complex activities, often with competing priorities. Most regulatory affairs positions ...

Job Description:           To assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials.  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 ...