VHB Medi Sciences Recruiting For Regulatory Affairs – Injectable ,Formulation Setup For ROW/GCC


Responsibilities and Duties

  • Should be well versed with Regulatory Affairs Guidelines of South East Asia, Africa, Middle East, LATAM, CIS Countries (ROW /GCC Market)
  • Knowledge of Preparation, compilation & review of CTD , ACTD & ECTD Dossiers.
  • Should be well versed in Handling customers & MOH query with respect to technical documentation (Stability Data, GMP, FSC, DMF etc.)
  • Well versed in IP /BP /USP pharmacopeia.
  • Should have a knowledge of applications of product permission , FSC, COPP
  • Should have knowledge of Loan License & P2P.
  • Artwork preparation as per respective countries guideline and Artwork checking.
  • Dispatching Sample for registration.
  • Keeping the record of registration status of all countries.
  • Should be aware about preparation of tender bids.
  • Inter Department coordination with Export / PPIC / Purchase / Artwork/ QA /QC / R& D/ Production & other related Departments.

Required Experience, Skills and Qualifications

  • Injectable Plant Experience shall be added advantage
  • Open to travel at Plant during Audits & other related work as per the requirement
  • Good Communication
  • Smart & Aggressive
  • Positive mind set
  • Open for suggestions
  • Science Graduate, preferably B.Pharm
  • Minimum 3 Years of Experience
  • Exposure in GCC / ROW Market will be added advantage.

Salary : Open for Right Candidate

Location : Kandivali , Charkop

Interested candidate can share their CV on nisha.ram@vhbgroup.com