Company: Titan Laboratories Pvt Ltd
Post: Executive Regulatory Affairs
Experience: 2-3 yrs
Qualification: Relevant
Location: Mumbai
OR Share your CV on shivali.k@titanpharma.com
Team Leader - Dossier preparation for eCTD market LATAM, ASIA market
New project Execution, Team handled for min 2 people, Should review MFR, PDR, BMR, PVR, SPECS MOA, STABILITY, ERA, NDMA. Should have knowledge of product lifecycle management
RFI Response, customer quires
Should be well versed with EMEA, TGA and ICH Guidelines. Should visit the site for required documents for dossier submission and RFI response as and when required
Should be strong in communication and correspondence.
Desired Skills: Quality, RND (Product development), Dossier Preparation eCTD format. Very well versed with EMEA Guidelines
Efficient Problem solving, Effective communication, creative thinking, Should be Bold /challenge seeker, positive attitude
No comments:
Post a Comment