35 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 ...

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 ...

Position:        Dy. Manager/Manager - RA Location:       Bhimpore - Daman Experience:   10 - 15 Years Industries:     Pharma  Responsibilities:        Develop and implement global regulatory strategies to ensure product approvals and Market access across multiple regions (FDA, EMA, MHRA, TGA, and Health Canada). CMC expert in handling the Initial Submissions ...

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 ...

Position:         RA Executive (Khopoli) Location:        Khopoli - Raigarh Experience:     5 - 6 Years Industries:      Pharma    Responsibilities: Dossier Preparation & Submission Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets. Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and ...

Key Responsibilities: Regulatory Returns Filing: Ensure timely and accurate filing of applicable regulatory returns. Regulatory Inspections: Maintain organized and up-to-date documentation to facilitate seamless inspections. Minimize observations during regulatory inspections through proactive management. Adhoc Requirements Submission: Ensure submission of adhoc requirements within specified time frames. Develop standardized processes for quickly ...

Duties and Responsibilities : Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy Timely compile materials for license renewals, updates and registrations Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted ...

Position Title :   Company Secretary Job Grade   Job Location Corporate Office Function/Department Corporate Governance & Secretarial Region India Reporting to Directors Finance Position Type Full Time Purpose of the Position (Job Summary) The Company Secretary is responsible for ensuring corporate governance, legal and regulatory compliance, and effective communication between the company, shareholders, and regulatory authorities. This role involves advising the board, maintaining statutory ...

Quality Assurance Administration, training, and auditing of Quality System Tools (Customer Complaints, CAPA, Training, Control Documents, Standards). Ensure compliance of quality procedures and work instructions with applicable standards. Conduct audits, training, preventive and corrective actions to maintain the QA system. Maintain training, qualification, and certification records of personnel. Approve/disapprove suppliers, vendors, facilities, equipment, processes, and ...

Experience to prepare and review the documentation required for the ISO 9001:2015, EN ISO 13485: 2016, Quality management System, WHO-GMP, EU MDR 2017/745, IMDR 2017. Knowledge and preparing documents such as Quality Manual, Site Master File, SOP’s, Change Control, Deviation, CAPA, Incident, and Customer complaint, Management Review Meeting, pdate Harmonized Standards, ...