1. Ensure regulatory input to product development CFT across each development stage (Preformulation, Setting of QTPP, Identification of CQAs and CMAs and their Risk Assessment, Formulation and Process Optimization using DoE, Pilot bio-studies, TechnologyTransfer, Scale-up establishing Design space and Exhibit batches)2. Preparation, review and timely submission of new dossiers [INDs, 505(b)(2) NDAs, ANDAs with US-FDA and ANDS with TPD-Health Canada]; Assure consistency and adequacy… Show more 1. Ensure regulatory input to product development CFT across each development stage (Preformulation, Setting of QTPP, Identification of CQAs and CMAs and their Risk Assessment, Formulation and Process Optimization using DoE, Pilot bio-studies, TechnologyTransfer, Scale-up establishing Design space and Exhibit batches)2. Preparation, review and timely submission of new dossiers [INDs, 505(b)(2) NDAs, ANDAs with US-FDA and ANDS with TPD-Health Canada]; Assure consistency and adequacy of all submission documents in line with the most recent regulatory expectations.3. Engage with regulatory agencies by ensuring timely response to the deficiencies received to secure fast-track approvals.4. Lifecycle management – Ensure filing of Annual Reports/ Annual Notifications on time; Strategizing Amendment/ Supplement filings of filed /approved products. Show less