Search Results: 2,109 vacancies
...activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of REG CMC... ....
About the Role
Your responsibilities include, but are not limited to:
Your responsibilities include, but are not limited to:
•...
...Job Description: Position : Assistant Scientist / Scientist - CMC (Formulation)
Reporting to : Lead scientist/Associate Director -CMC
Location : Hyderabad, India
Education/Qualifications : M. Pharm/Ph.D from premier institute.
Experience : At least 7-9 years...
...Job Description: Position: Assistant Scientist / Scientist - CMC (Formulation) - Injectables
Reporting to: Lead scientist/Associate Director -CMC
Location: Hyderabad, India
Education/Qualifications: M. Pharm/Ph.D from premier institute.
Experience: At least...
...to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Position Summary
The CMC Regulatory Associate Director, Small Molecule is responsible for content development, compilation, maintenance, and review of the...
Analytical method development and pre-validation involved in assigned projects
Analytical support for formulation development, optimization & scale-up, as applicable
Support Analytical method validation and method transfer involved in assigned projects
Preparation ...
...Author high quality global CMC documentation for Health Authority submission throughout
the product lifecycle, applying agreed CMC global regulatory strategies, current regulatory
trends and guidelines.
Ensure technical congruency and regulatory compliance, meeting...
...with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module...
...Manager- Sales & Marketing
Grade : Manager
Location: Hyderabad, Telangana
Company: Hitachi Hi-Rel Power Electronics Private Limited
Salary Range: As per the industry
Company Overview :
Hitachi Hi-Rel Power Electronics Private Limited ( ) is recognized...
...Development (GDD).
Your responsibilities will include, but are not limited to:
• Design, plan and perform scientific experiments for... ...stakeholders and handle multiple priorities.
• Provide input into CMC documents to support regulatory submission and respond to HA...
...multiple domains- regulatory submissions, clinical trials, marketing authorization applications (MAA), chemistry manufacturing and controls (CMC), CMC variations, pharmacovigilance projects, and regulatory strategy, among others, and we would love to speak with you if you have...
...highly capable teams.
Your responsibilities include, but are not limited to:
• Creates and maintains the end-to-end supply plan from CFG... ...regulatory aspects by contributing to GCS agenda at TRD Sub team CMC meeting. Represent GCS at TRD Sub-team on supply chain aspects....
...efficient, timely and clear communication to all involved partners (on-site and off- site incl. to global product lifecycle leader and RA CMC) as required for flawless project execution in collaboration with project leader
• To communicate project progress and deviations as...
...to the Life Cycle Implementation Expert (LCI). Is responsible and accountable to develop together with the responsible functions in RA-CMC and RA the regulatory submission strategy and in conjunction with E2E-Supply Network Planning Manager, Sites, Markets and other stakeholder...
...NDA and other related supplementary application on the targeted date.
Ensure license renewal Submission and approval on time; Ensure CMC/BPI/PSUR/RMP in line with NMPA regulation and Novartis internal policies; Ensure registration master file update.
Assist to...
...supports the planning, organization, and review of routine submissions for clinical, nonclinical, chemistry, manufacturing and controls (CMC) and regulatory.
Position Responsibilities
Should be pulled from the appropriate Job Description data in Workday, appropriate...
...Prepare/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, Product Development Reports, QOS, QbR and other CMC documents for regulatory filings.
Independent product development and stakeholder management skills to build strong connections with...
...submitted in alignment with the business goals.
Conduct technical review of documents and provide regulatory expert advice, and approve the CMC, non-clinical, clinical, labeling documents and technical packages authored by team members to ensure completeness, accuracy and...
...ensure implementation of SHE and QMS at work place.
To draft the study protocols, method development reports, comparability reports and CMC sections of regulatory documents
Maintenance of laboratory as per the cGLP.
Having the good writing, presentation and...
...development/qualification
3. Technology transfer and support analytical methods required for product Analytics.
4. To guide and create CMC package on a timely manner.
5. Ensure proper usage and maintenance of equipment/ instruments/columns.
6. Maintenance of proper...
...development and above is mandatory)- Strong knowledge of writing SQL/PLSQL and indexing Minimal Configuration and Administration using CMC - Understanding of HANA view and promotion management - Good to have SAP BOBJ Rest SDK Enterprise SDK integration experience - Function...
