Pharma

 Executive/Senior Executive/ AM - DRA (Regulatory Affairs)

  • Industry

Pharma

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  • Location

Baddi

 

  • Qualification

Pharma Graduation

 

  • Experience

2-6 yrs 

 

  • CTC 

As per Industry Standards

 

Job Role :

Regulatory filing of the Human Drug Products(Generics and Innovative Product),specifically for the  countries like Singapore, Korea, GCC, Algeria,South Africa, Malaysia, Turkey, Serbia, Bosnia, Taiwan, Algeria, Kosovo.

  • Regulatory guidance, review, filings of new product registration dossiers, change variations and renewals applications.
  • To act as an interface between regulatory agency and internal stakeholders.
  • Review of the outsourced DMF as well as complete product CMC/ non clinical / clinical documents.
  • Responsible for post approval compliance & providing assistance to registration body for GMP accreditation applications & its renewal.
  • Assist during international regulatory audits at sites.
  • Supporting the internal stakeholders by providing the regulatory requirements.
  • Ensuring that company’s products comply with the regulations of the respective Regulatory Agency.
  • Monitoring and setting timelines for license variations and renewal approvals.
  • Advising scientists and manufacturers on regulatory requirements.

 

Technical Skills

  • Thorough knowledge of EU/ ICH/ GCC guidelines.
  • Scientific Writing Skills.
  • Hands on Experience on filingexposure in developed countries.Regulatory exposure from development to launch of new product.
  • Comprehensive Knowledge and Experience of Chemistry, Manufacturing and Control (CMC)/ Non clinical/ clinical documents.
  • Regulatory Exposure from development to launch of new products.

Kindly share your CVs on duniya@samridhiplacements.com