65 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 ...

Role: Principal Regulatory Affairs Specialist Location: Trumbull, Connecticut, USA Salary: USD 100000 - 130000 CLIENT :          Our client, a leader in the consumer products industry is looking for a Principal Regulatory Affairs Specialist.  You’ll be part of an organization that’s shaping the future through innovation, sustainability and collaboration.  They offer exposure to cutting edge ...

Job Title: R&D Executive – Dossier / Regulatory Affairs No. of Positions: 3Company: Concept PharmaLocation: AurangabadCTC: ₹NegotiableExperience:  1–2 YearsQualification: B.Pharm / M.Pharm Job Summary Concept Pharma is seeking R&D Executives (Dossier / Regulatory Affairs) to support preparation, compilation, and submission of regulatory dossiers for pharmaceutical products. The role is suitable for freshers as well as candidates with up to 1–2 years ...

Job Description – Regulatory Affairs Specialist Company: Concept Pharma Pvt. Ltd. Position: Regulatory Affairs Specialist Vacancies: 2 Experience: 5–10 Years CTC (Budget): Negotiable Location: Aurangabad Key Responsibilities Lead and manage the compilation, preparation, and submission of regulatory dossiers for domestic and international markets in ACTD/CTD formats. Ensure full compliance with CDSCO regulations and global regulatory requirements ...

    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 ...

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 ...

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 ...