DifGen Pharmaceuticals

Senior Research Associate

DifGen Pharmaceuticals  •  State of Telangāna, IN (Onsite)  •  5 months ago
Apply
AI can make mistakes so check important info. Chat history is never stored.

Job Description

Job Location Prashanti Nagar IE Kukatpally Hyderabad, Telangana 500072 Job Shift Day

  • Prepare submission check-list based on regulatory & product specific requirements
  • Dossier compilation and review of ANDA’s for different dosage forms.
  • Review of all technical documents which are required for ANDA compilation (Specifications, STP, COA’s, protocols, BMR’s, BPR’s, Bio related documents etc....)
  • Review of documents (Master BMR’s, Master BPR’s, specifications, protocols, EIR report, IIG etc...) received from other cross functional teams for the products under development.
  • Preparation and review of controlled correspondences for different dosage forms as per the R&D request.
  • Compilation of sections required for query responses received from Agency.
  • Communicating with the cross functional teams and CMO’s for requesting the documents required for ANDA compilation.
  • Compilation of post approval submissions (CBE-30, PAS) if applicable
  • Checking for the current version of documents for submitting it to Row market as per requirement
  • Preparation of checklists (to review the BMR, BPR, ANDA document request, ANDA checklist for internal references).
  • Checking for USFDA current updates and new Guidance’s published in website.
  • Training to fresher in the department with all Regulatory Affairs aspects.
  • Reviews document change controls.
  • Support the maintenance of regulatory files and databases, ensuring accuracy and completeness of documentation.
  • Following with USFDA and EMA sites for current updates.
  • Any other related duties as assigned by Team Leader

M.Pharmacy

B.Pharmacy/M.pharmacy with experience of 4 to 8 years in Formulation Regulatory Affairs.

DifGen Pharmaceuticals

About DifGen Pharmaceuticals

We are a US based Global Pharmaceutical company with a primary focus on developing complex high barrier to entry Generics and Specialty Pharmaceutical products that would help increase accessibility to high quality medication thereby leading to the creation of next generation healthy communities. We are driven by an earnest pursuit of redefining the accepted standards in pharmaceutical product development and commercialization. We consistently aspire to challenge standard thought processes to arrive at dependable solutions that create a paradigm shift in product development, quality, clinical affairs, regulatory sciences, and commercial strategy. Our talented team with some of the brightest minds have developed a holistic understanding of the nuances associated with the development of unique, commercially viable and difficult product lines across varying therapeutic areas and a broad array of dosage forms such as Injectables, Ophthalmics, Topicals, Biologicals, Drug Devices, Soft Gels, Solid Orals & Suspensions.

Industry
Chemicals & Materials
Company Size
51-200 employees
Headquarters
Hyderabad, IN
Year Founded
Unknown
Social Media