Executive Regulatory Affairs

Job Profile:

a) Summary:

Required Candidate with Full-time degree course in B. Pharm/M. Pharm from a recognized university with experience of at least 5 to 8 years in the Regulatory affairs in the Pharmaceutical Industry.

b) Job Responsibilities:

• Maintaining compliance with WHO GMP, PIC/S & Schedule M Guidelines.
• Preparing 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
• Leading Regulatory, Customer and Certification audits
• CAPA management
• Coordination with marketing, development, purchase, QC and stores on day-to-day basis for requirements and support.
• Tracking updations and changes in applicable guidelines for future applications.
• Training to sub-ordinates on GMP, GDP & Regulatory requirements.
• Co-ordinating with local FDA and CDSCO for various permissions.

c) Required Skills:

• Very Good English Communication and Writing Skills.
• Profound knowledge of Schedule M, WHO GMP, PIC/S & USFDA.
• Good Understanding of regulations, guidelines, procedures, and policies relating to development, registration and manufacturing of drug to expedite the submission, review and approval of global applications.

d) Perks and benefits:

PF, Gratuity, Bonus, Mobile usage reimbursements, Mediclaim commute services, employee accidental insurance.