62 Job openings found

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:      Asst. Manager - QA Location:      Daman Experience:  8 - 15 Years Industries:    Pharma Responsibilities: To maintain a robust Quality Management System (QMS) aligned with regulatory expectations. To handle internal, external, and regulatory inspections, ensuring successful outcomes and continuous compliance readiness. To handle compliance of deviation management, change control, Market Complaint Recall, ...

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 ...

  Job Description: Regulatory & Compliance Manager     1. Position Description   Job title Regulatory & Compliance Manager     Department QA Reports to Vice President-R&D Direct Reports - Location Daman       2. Job Purpose   Job Statement Job purpose Ensuring that our master batch and additive solutions meet or exceed the compliance expectations of customers, certifying bodies, and regulatory agencies in both domestic and international markets   3.  Basic Qualifications   Job Requirements Education M.Sc / ...

Summary The Estimation & Proposal Engineer in a pharmaceutical consultancy will be responsible for developing accurate, competitive, and technically-sound cost estimates, proposals, and tender submissions for pharmaceutical projects (e.g. process design, utilities, cleanrooms, HVAC, validation, regulatory compliance, etc.). They collaborate with cross-functional teams (engineering, procurement, quality, regulatory, project management, sales) to ...

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 ...

Position:        QA Manager Location:        Ankleshwar Experience:     15 - 18 Years Industries:     Pharma - API   Responsibilities: Day to Day planning and execution of various activities in QA Execution/review/Approval & monitoring of process validation activities. Preparation, review, Approval of process validation Protocol/Report. Preparation, review and Approval of Annual Product Reviews Handling of Change Controls ...

The job description is as below: Keep in touch with international legislation, guidelines and customer practices  Keep up to the date with a company’s product range Ensure that a company’s products comply with the current regulations. Coordinate, prepare and review all appropriate documents, for example, dossier and submit them to regulatory authorities within a ...