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 [email protected]
