Sr. Executive - RA

Job Description:

Position:         Sr. Executive - RA

Location:        Daman

Experience:     7 to 8 Years

Industries:      Pharma

Responsibilities:

• Maintaining compliance with Dossiers, ISO 13485, WHO/GMP requirements.
• Preparing technical and Drug master files
• Preparing and compiling documents for registration to various countries.
• Reviewing and updating of documents w.r.t various regulatory requirements
• Reviewing and updating of documents w.r.t various applicable standards
• Risk management, clinical evaluation, and Pharmaco-vigilance.
• Leading Regulatory, Customer and Certification audits.
• CAPA management.
• Training to sub-ordinates on Regulatory.
• Co-ordinating with local FDA and CDSCO for various permissions.

 Required Skills:

•  Profound knowledge of USFDA and EU Submission, ISO 13485.
•  Good Understanding of regulations, guidelines, procedures, and policies relating to development,registration and manufacturing of drug-device to expedite the submission, review and approval of global applications.

 Required Qualification: - B.Pharm/M.Pharm/B.Sc/M.Sc

Salary :- Upto 9.00 LPA

If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-