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Freyr Software Direct & Virtual Walk in 19th March 2022 for CMC Regulatory Affairs

SWARNALATHA B March 14, 2022

Freyr Software Services Pvt. Ltd Walk In Interview 2022  M.Pharma for CMC Regulatory Affairs -US, EU Markets At Hyderabad/Secunderabad. Freyr Software Services Pvt. Ltd Notification full details below..Interested and eligible candidates can attend interview on scheduled time and venue.

  • Vacancy details:
  • Post Name: CMC Regulatory Affairs -US, EU Markets
  • Qualification: M.Pharma    
  • Experienced: 04 to 9 years of Experience
  • Salary:₹ 9,00,000 – 16,00,000 P.A.
  • Openings:NA

Job Description: Freyr Software Services Pvt. Ltd Hiring For CMC Regulatory Affairs -US, EU Markets !

  • Important Details :
  • Location: Hyderabad/Secunderabad
  • Post of date: 14/03/2022
  • Contact – Yasmin Mohammed ( 04048480999 )
  • Selection Process: The selection will be on the basis of Interview.
  • Interview Date:19th March , 
  • Interview Time:10.00 AM – 5.30 PM
  • Venue:Freyr Software Services Level 4, Building No. H-08 Phoenix SEZ Avance Campus Back side of Cyber gateway, Beside Dell Office HITEC City 2, Gachibowli Hyderabad 500081 India
  • If Candidates are interested to direct walk-in can come to the above mentioned address.
  • Candidates who are interested to attend virtual walk-in please apply for the above position.

Job Description :-

  • Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines throughout project lifecycle
  • Prepare CMC responses to health authority questions during development, registration and product lifecycle
  • Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
  • Gap analysis and authoring of MAA for Generic drugs for EU , US & ROW countries
  • Experience in handling dosage forms like, Orals, Sterile, Ophthalmic, Topicals, Inhalaers…
  • Real time experience in handling the end to end registration procedures like CP, DCP, MRP, NP
  • Experience in provide the regulatory pathways and strategic inputs for EU countries, US Market & ROW Markets
  • Change control assessment and strategy preparation
  • Expertise in preparation of post approval submissions like variations, Renewals for Eu countries
  • Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned
  • Establish and maintain sound working relationships with partners and customers
  • Handling the response to HA queries
  • Excellent communication skills
  • Team management capability

About Company:

Freyr is one of the largest global, Regulatory-focused solutions and services companies for the Life Sciences industry supporting, Large, Medium, and Small size global Life sciences companies (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar

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