37 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 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 ...

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 ...

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, ...

Responsibilities: Corporate Governance: Oversee and ensure compliance with all legal and regulatory requirements. Manage and organize board and committee meetings, including thepreparation of agendas, minutes, and resolutions. Maintain and update statutory books and records. Loan Documentation: Coordinate and manage the end-to-end process of loan documentation. Collaborate with legal and financial ...

The job description is as below: The R&D Manager - NDDS will lead formulation and development of novel drug delivery systems, from concept to scale up and tech transfer, ensuring compliance with regulatory and quality standards and alignment with business goals. The role requires strong scientific depth in NDDS, team leadership ...

Designation –  HE&R Analyst - APAC (Health Economics & Reimbursement) Qualification – Any Graduate  Work Timings – 9:00 am to 6:00 pm (may require flexible hours to accommodate calls with Global and Regional teams) Working Days – Mon - Fri Work Location –  Hyderabad Salary – Best in industry Experience – 2+ years Note: This role will be on ...