Kusum Healthcare is a young & dynamic pharmaceutical company having two manufacturing units, one each in India (Bhiwadi- Rajasthan) and Ukraine (Sumi). Both these manufacturing units are WHO GMP and PIC/s certified.
Company has a team of more than 1660 employees working at various locations with 15 of them being Ph.D. and 241 MD

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With the head office in Delhi- India, Kusum has representative offices and full-fledged operations with complete sales, marketing, logistics, and distribution set up in Ukraine, Kazakhstan, Uzbekistan Moldova, Tajikistan, and Myanmar.

Kusum is the number 1 Indian pharmaceutical manufacturer in terms of sales in Ukraine, Kazakhstan, and Uzbekistan.

Position: Asst Manager/Sr Executive – Regulatory Affairs

Location: Okhla, Delhi

Job Description:

Roles and Responsibilities:

  • Understanding of ICH, USFDA, WHO guidelines of regulatory.
  • Review of technical documents i.e. API row data, BMR, PVP/PVR.
  • Knowledge of reviewing analytical validation, DMF.
  • Sound knowledge of ICH guidelines.
  • handled filing of semi-regulated market & post-approval changes.

Desired Candidate Profile:

  • Command over written and verbal English communication.
  • Working Knowledge of Mexico, Brazil, Australia, South Africa, New Zealand & Malaysia.
  • Proficient in computer skills
  • Commitment and ownership.
  • The proactive and problem-solving approach
  • Ability to work with tight timelines.

Qualification: B.Pharma, M.Pharma

Experience: 4-6 Years

Salary: Negotiable

Contact Details:

kusumhealth@kusumhealthcare.comrajat.hr@kusumhealthcare.com, yogendra.mishra@kusum.com

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