65 Job openings found

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 ...

Must be Graduate/Post Graduate with about 3 to 4 years in working for Industrial Project in Chhattisgarh. Canditate must be based at Raipur         The Liaisoning Officer is responsible for establishing and maintaining effective communication and coordination with government departments, regulatory bodies, local authorities, and other external stakeholders. The role involves managing ...

DMF API Submission experience is must Preparation of New Drug Master Files as well as DMF amendments for Brazil, US, and ROW market according to respective agencies requirements. Preparation of Applicant part of DMF for Brazil, US, and ROW market. Preparation of all administrative statements for respective authority requirements. Drafting of regulatory response for ...

Job Description   -Compilation and submission of eCTD dossier for new product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US) -Hand on experience in preparation of CTD section as per regulatory requirements of different region -Having experience in preparation of query response and PAS, CBE and annual report. -Have ability to co-ordinate with ...

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 ...

A Sr. Manager Liaison manages relationships with government bodies, regulatory authorities, and external stakeholders to secure timely project approvals, ensure statutory compliance, and facilitate smooth operations, often in real estate or infrastructure, requiring strong networking, negotiation, and documentation skills to bridge organizational needs with external requirements and mitigate risks.    Key Responsibilities: Government & ...

Sound knowledge and experience in completing full life cycle of any ISTS project from regulatory aspects. Essential knowledge of requirement of permits and approval for an ISTS project like Sec 68, Sec 164 before and after COD including during construction. Must possess experience in Testing procedure, First Time Charging (FTC), Trial ...

The Regulatory affairs team supports all the departments within the organization towards all regulatory requirements including approvals, reports, information sought etc. Such regulatory offices include DGCA, Various Ministries, AAI etc. The official under the role w The Regulatory affairs team supports all the departments within the organization towards all regulatory requirements including approvals, reports, information ...

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, ...

We Are Hiring API Export Manager In Ahmedabad Job Title: International Sales/Exports PositionsLocation : Ahmedabad(Only Male Candidates Can Apply)  Job Title: API Export Manager  Key Responsibilities: Lead API sales growth in the GCC region by identifying, approaching, and developing new business clients. Manage and maintain strong relationships with existing customers, ensuring retention and satisfaction. Handle customer queries ...