MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has nine API and five finished dosage facilities established across Hyderabad, USA and Myanmar.
API – Analytical Research & Development (API – AR&D)
Department : AR&D – API
Job Description : Method Development & Method Validation -AR&D – API Division
Requirements : HPLC / Ion Chromatography/ LCMS/ GCMS/ HPLC / GC /Method Development / Method Validation/ Regular Analysis/Support Analysis / ICP MS/ Oncology
Position : (API – AR&D) Executive / Senor Executive / Junior Manager
Experience : 2 to 10 Yrs
Executive / Senior Executive / Junior Manager / Assistant Manager / Manager - Regulatory Affairs
Job Description (Regulatory Affairs – API Division) : Should have minimum of 2 to 15 years of experience in API Regulatory Affairs
Education : B Pharma / M Pharma / M.Sc
Department : Regulatory Affairs
Job Profile :
1. Collecting and reviewing the documents received from various departments R&D, AR&D, QA, QC and Production etc at each and every stage of manufacturing of drug substances to minimize the errors at the time of submission to regulatory agencies.
2. Hands on experience on the preparation of DMFs and their registration processes in the major regulatory regions [US, Canada, Europe etc]..
3. Hands on experience on preparation of drug master files, Applicants Parts, Tech Pack, life cycle management [updates and amendments] and drafting of response to deficiencies and customer DMF review comments for all global regions.
4. Should have hands on experience on eCTD regulatory submission tools.
5. Should have knowledge on the requirements to respond to the deficiencies.
6. Participation in the cross functional team meetings and providing regulatory inputs to the Product Development Teams.
Junior Manager / Assistant Manager / Manager
Experience : 8 to 15 years in API RA field Education: M Sc
Department : Regulatory Affairs
Job Profile :
1. Good scientific conceptual background to the level to evaluate the processes and procedures in the area of Quality, R&D, AR&D and Production.
2. Manageable communication in English [should be able to manage regulatory and scientific discussions in the internal and external meetings and one to one interactions within the organization and with customers]
3. Manageable knowledge on the regulatory and quality guidelines from various regulatory agencies ICH, FDA, EMA, Health Canada, ANVISA, PMDA, MFDS, CFDA etc.
4. Thorough knowledge and hands on experience on the DMF registration and marketing authorization application systems in the major regulatory regions [US, Canada, Europe etc]..
5. Hands on experience on preparation of drug master files, life cycle management and drafting of response to deficiencies and customer DMF review comments for all global regions.
6. Should have knowledge on product developmental and the quality systems to ensure the regulatory compliance.
7. Should have hands on experience on eCTD regulatory submission tools.
8. Conducting meetings for the deficiencies received from various regulatory agencies and should have knowledge on the requirements to respond to the deficiencies. Ensuring that the accurate and adequate responses are sent to the authorities within the timelines defined by agencies.
9. Thorough review and ensuring that the regulatory submissions are adequate and error free with minimum open issues and closing of open issues before filing or before the receipt of deficiencies.
10. Participation in the cross functional team meetings and providing regulatory inputs to the Product Development Teams.
11. Reviewing the documents received from various departments R&D, AR&D, QA, QC and Production etc at each and every stage of manufacturing of drug substances to minimize the errors at the time of submission to regulatory agencies.
12. Review and assessment of change controls and providing guidance to the team on proposed changes.
13. Ensuring that the regulatory databases are properly maintained and updated on time to time for each regulatory activity.
Executive / Senior Executive in Intellectual Property Management (IPM)
Experience : Candidate should have minimum 2 to 6 years of experience in IPM Dept
Executive / Senior Executive / Junior Manager
Department : IPM – API & Formulation
Job Description : Formulations IPM
• Identification/Selection of molecules for development
• Preparing Patent Clearance Reports
• Preparing Preliminary Patent Assessment Reports
• Searching for patents equivalents and their legal status for various country databases
• Patent Monitoring
• Infringement analysis
• Patents searching for formulation projects
• Preparation of IPR Assessment reports
• FTO & Infringement Analysis
• New Product Evaluations
• Patent Strategies for Orange Book Patents
• Identifying opportunities for early market entry by making strategies
• To frame launch timelines of products for various countries by reviewing the patent landscape and analyzing IP of blocking patents for launch
• Preparing response to the queries raised by Business Development team.
• Drafting Patent Specifications
• Weekly updation of patents/publications
Formulation Analytical Research & Development (FAR&D) Dept
Job Description : (Solids Orals / Injectables / Complex Injectables FAR&D – Formulation Division)
Requirements :
Oral Solids / Injectables / Complex Injectables / Regular Analysis / Support Analysis / Method Validation / Method Development/ Oncology/
Position : (FAR&D) Executive / Senor Executive / Junior Manager
Experience : 2 to 10 Yrs
Interested candidates may forward your resume to this mail ID – simhachalam.piniminti@msnlabs.com
Note : Candidates are requested to bring resume, Photo copy educational certificates, latest increment letter, Last three months Pay Slips, Last Six Months Bank Statement ,passport size photograph Aadhar card copy
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