Novartis is Hiring For Regulatory-CMC Manager-Quality Operations and has issued notification to accept Applications.Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. Eligibility for the Regulatory-CMC Manager-Quality Operations as follows.
Vacancy summary details :
- Company Name: Novartis
- Location :Hyderabad
- Post Name: Regulatory-CMC Manager-Quality Operations
- Education: Degree or Masters in Science or Pharmacy
- Experienced: 10+ years
- No of Vacancies: Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Closing date for online Application : Apply as soon as possible
- Date of examination: NA
- Time and Venue :NA
- Mode of application : online
- Selection Process: Shortlisted candidates may called for selection process ( Personal interview , Group discussion , etc…,)
Job Description/Skills Required:
• Manage and facilitate ESO regulatory CMC related activities resulting from change projects (including transfers, divestment, pruning and due diligence activities) and remediation activities of the External Supply specific (global and local) products in order to ensure timely supply to the markets in compliance with up to date regulatory requirements.
• Act as single point of contact for worldwide regulatory intelligence information within ESO, maintain the knowledge of the global dossier (CTD module 3) for IM products supplied by the External Supply in order to advise on the regulatory impact of changes.
• Act as member of the local ESO change control review board and determine the category applicable to each change request issued and perform the pre-evaluation of category II change requests and the full regulatory evaluation of category I change requests
• Coordinate the collection and timely provision of complete and consistent source documentation to Global Reg. CMC needed for the preparation of the CMC variation dossier. Facilitate the preparation of CMC responses to health authority questions and support the requests from MAH during HA audits.
• Drive the co-ordination and provide timely review comments of the prepared CMC documentation as required for P2P or MAH products. Follow-up the availability of necessary reports (e.g. stability reports) and perform quality checks. Monitor and make the follow-up of the preparation of samples in special cases (e.g. for stability or registration).
• Prepare, co-ordinate and track regulatory commitments (“Statements / Commitments”) by maintaining an appropriate process and database (e.g. DRAGON and/or NovaRIM etc). Ensure compliance with the legal requirements of the local HAs (GMP Certificates, Export Certificates, Import Certificates, Manufacturing Authorization, etc).
• Train and develop the ESO personnel and suppliers on regulatory specific aspects of change management by sharing lessons learned and regulatory intelligence information with the goal of improving their skills and capabilities for handling change requests and keeping the highest level of compliance. Support projects as needed e.g., check the compliance of the dossier for launches, transfers, divestments or changes or gap assessments (incl. dissolution profiles, stability reports, validation reports, CoAs, MBRs, EBRs, etc)
• Maintain a close collaboration (and self-training) with Global Reg CMC in order to keep track with new regulatory requirements and Global Reg CMC strategies.
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.
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