# Responsible for the registration of New/renewal drug products in regulated and semi-regulated market.# Accountable for eCTD sequence generator, modifier, uploader, validator and publisher of dossier.# Mange the registration process, associated deficiency, annual plan and post approval changes– life cycle management of products.# Accountable for the writing of CMC data from the ODMF, product development report, active/excipients/finished product release/shelf-life specification, method, COA, test standards, process validation studies, stability studies, analytical method validation to meet the ICH, GMP and GLP requirement and artwork, insert/PIL preparation and maintain its database.# Interacting with regulatory bodies, managing relationships with regulators and being able to communicate and present technical elements in a way that the regulator can understand.# Partnering with teams across the business, identified opportunities to create and improve process change, enabling quicker market access for new and modified products.# Ensure the requirements of Bio-equivalence study, its reports, Periodic safety update report, Pharmacovigilance Site master file and Risk management plan for the New/registered products.# Prepare the annual budget of GMP audit, product registration (consulting/MOH and licensing) fee, variation activity and to take approval from the management every year.# Responsible for the licensing work like application of the manufacturing license, WHO GMP, GLP, product permission, COPP, free sale certificate application for registration and compliance.

# Responsible for the compliance of manufacturing site to cGMP and customer requirement for the registration of products in regulated and semi-regulated market. # Accountable for vendor qualification programmer and communicate with supplier and manufacture of the API, excipients and packaging material. # Collaborating with cross-functional teams such as Product development, Quality assurance and control, Production, supply chain, Distribution, Marketing, commercial and acting as an interface to provide guidance on regulatory and compliance matters to ensure products meet regulatory requirements and standards.# Accountable for arrangement and review of ODMF, product development report, active/excipients/finished product release/shelf-life specification, method, COA, process validation studies, stability studies, analytical method validation to meet the ICH, GMP and GLP requirement. # Accountable for arrangement of exhibit batches from R& D lab to manufacturing site and site transfer from registered site to new propose manufacturing site. # Ensure the constant change in the regulatory body and conducting regulatory impact assessments to identify potential issues and develop mitigation plan for any changes that might have an impact on the business.

# Faces of audits: 21 CFR Part (US), EU GMP/EDQM, TGA, PICs, INVIMA, GCC, MCAZ, Kenya, JFDA, ISO 9001, FSSAI, WHO.# Accountable for the compliance of routine batch manufacturing, procedure relating to validation, In-process quality control, packaging, stability studies at manufacturing site level and release of active, inactive, packaging and finished products through SAP/ERP system to meet the GMP/GLP standards.# Responsible for the writing and review of plant procedures relating to manufacturing (SOP), validation and compliance.# Manage the change control, incident, deviation, corrective and preventive action (CAPA), market complaints using root cause analysis as part of Quality Management system.# Ensure timely execution of the validation master plan (VMP) for the activities like media fill, qualification (IQ, OQ, PQ) of all the machines/equipment’s, system (HVAC, Utility, Transportation) and process.# Provide consultation and direction to the plant in relation to all validation and compliance matters.# Drive and implement continuous improvements to enhance operations and participate in related cross-functional projects.# Responsible for the external audit program for raw material and packaging component suppliers, as well as third party laboratories and suppliers of critical services and ensure the compliance to all policies, standard as well as procedures are being followed by the company