Cmc

**Trainee CMC** The Trainee - Regulatory Affairs will be a part of the GRACS team which supports regional CMC strategy, preparation of CMC documentation. Under the direction of the area supervisor, responsible for the planning, preparation, and release of regulatory submissions (IND/CTA, NDA/BLA/MAA, post-approval supplements, annual reports, etc.) and...

This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance’s and defined regulatory strategies. He would even be responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Our Regulatory...

**Associate Director, Regulatory Affairs CMC** The Associate Director is responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidance’s, and our company's procedures. Would also lead the preparation and submission of CMC dossiers for life-cycle changes to...

**Scientist Regulatory Affairs CMC** This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance’s and defined regulatory strategies. He would even be responsible for the preparation and review of information required for development of regulatory CMC dossiers for...

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...

**About us**: We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful...

As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously. You will interpret and advise teams on global guidelines, procedures and...

As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously. You will interpret and advise teams on global guidelines, procedures and...

As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously. You will interpret and advise teams on global guidelines, procedures and...

**Must be able to come for Interview in Andheri/Vasai** **Joining**:Immediately **Location**: Vasai East **Qualification and Requirements**: - Graduate, Bachelor’s degree in Engineering, Biomedical Engineering, or a related field - 2+ years of experience in a service coordination role, preferably in the medical equipment industry. - Strong...

1) Complete understanding of requirements & regulations of ASEAN/ AFRICA/LATAM/ GCC/ MENA markets wrt New submissions, Re-registration & Variations. 2) Prior experience of carrying out high quality CMC review of all kind of technical documentation & Art-works, 3) Review and /or Compilation of country specific/ CTD/ACTD dossiers for new submissions &...

a) Excel Knowledge b) Knowledge of AMC / CMC c) Have handled repairs and maintenance d) Housekeeping and Stationery e) Should posses complete administration experience. g) Position is located in client place at Bandra **Salary**: ₹11,392.95 - ₹25,000.00 per month **Benefits**: - Health insurance **Education**: - Bachelor's...

Follow up on AMC& CMC payments / Co-ordination activities for transportation of lab equipment's / Preparing tender documents, quotations for sales, indents for outside purchase of equipment's / Maintain records of documents / All co-ordination activities for transportation of Lab Equipment’s / All other office works, etc. **Salary**: ₹16,000.00 -...

Follow up on AMC& CMC payments / Co-ordination activities for transportation of lab equipment's / Preparing tender documents, quotations for sales, indents for outside purchase of equipment's / Maintain records of documents / All co-ordination activities for transportation of Lab Equipment’s / All other office works, etc. Pay: ₹18,000.00 - ₹27,000.00...

To have knowledge of medical equipment's and installation To setup ICU related equipment facility at home Maintenance of equipment's AMC and CMC of Equipment's Planning and budgeting of new equipment's vendor negotiations Record Maintenance of all equipment's **Job Types**: Full-time, Permanent, Fresher **Salary**: ₹20,000.00 - ₹30,000.00 per...

To have knowledge of medical equipment's and installation To setup ICU related equipment facility at home Maintenance of equipment's AMC and CMC of Equipment's Planning and budgeting of new equipment's vendor negotiations Record Maintenance of all equipment's **Job Types**: Full-time, Permanent, Fresher Pay: ₹25,000.00 - ₹30,000.00 per...

Preferred Experience: 2-15 Years in Pharmaceutical industry with major experience in Global Regulatory Affairs function. Authoring and/or contributing line to CMC content for New Development & Post-approval Variations/ Supplements for Chemical Entities, Biologicals, Vaccines (INDs/ IMPDs/ NDAs/ BLAs/ ANDAs/ MAAs/) & Medical Devices (PMA/ 510(K)/ Notified...

Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our...