Tablet Capsule Experience is Mandatory/ROW,EU Market.The major responsibilities will be to prepare documents for registration of products, marketing and legal compliance of pharmaceutical products in order to control their safety and efficiency. i) To review quality documents required for preparation of dossiers. ii) To review regulatory and administrative documents required for preparation of dossiers. iii) To prepare/review CTD, ACTD dossiers and/or dossiers as per respective country guidelines. iv) To arrange submission for variation application. v) To prepare compliance against regulatory queries regarding registration of products. vi) Custody of registration samples. vii) To review artworks of packaging materials. viii) To review Standard Operating Procedures as and when required. ix) To review and arrange the regulatory documents for tender application. x) To provide necessary training as and when required. xi) Other Regulatory Affairs related documentation work. xii) Any other work assigned by superior
