Regulatory Affairs Manager
MicroSynergy Pharmaceuticals
مجموع سنوات الخبرة :18 years, 10 أشهر
Regulatory Department Structuring:
•Create, define and structuring sustainable regulatory department.
•Prepare, approve and implement regulatory SOPs and associated quality procedures as required.
•Provide training and leadership for newly joined RA employee.
Regulatory Submissions & Process (Know-How):
•Prepare the Marketing Authorization Applications (MAA) and consequent regulatory Submissions (Renewals, CMC Variations) by interaction with other departments (QC, QA, BD, R&D, Supply Chain…) for assigned products and territories in line with national requirements and company standard procedures.
•Review and advice on content of the registration dossier to fulfill local requirements and ensure fast track submission.
•Ensure implementation of the pre-defined registration plan for selected products and territories and make sure to meet target completion date (TCD).
•Use all possible strategies and competencies to improve quality and efficiency of submissions.
•Maintenance of registered products data base in order secure supply, business continuity and avoid drug shortage.
•Support manufacturing site registration in line with national requirements as well as WHO GMP audit checklist.
Labelling Management:
•Support packaging development team for preparation or revision of product labelling accordance with local requirements and compliance with company standard procedures.
•Review of Arabic Translation if needed.
•Review container closure system updates and advise about regulatory requirements for implementation.
•Make sure product packaging and related information is updated and maintained in registration database in accordance with the product license.
•Collaborate with Pharmacovigilance team regarding submission of urgent safety restrictions or updates.
•Focus to increase patient safety as well as reduce medication errors by implementing Track & Trace system and identify products require implementation as per local requirements. (Serialization & Aggregation).
Regulatory Intelligence (RI) :
•Gather the information from public and official communications, evaluate the gaps, identify the risks then highlight the opportunities and communicate the RI for better decision making.
Regulatory Information Management:
•Daily, weekly and monthly plan monitoring.
•Maintain regulatory records up to date.
•Create proper filling database.
•Prepare regulatory KPI and keep close monitoring on YTD achievements.
•Identify and validate RIMS tools for proper RA e-Transformation.
Process Improvement.:
•Monitor and validate all regulatory changes at national and international levels.
Regulatory Compliance & Quality Management (QMS):
•Ensures regulatory compliance with local regulations, guidelines and legislations.
•Deviation Management.
•Change Control Management.
•Internal audit/ Self-inspection management.
•Supplier/ Vendor Management.
•Document Management.
Commercial Support:
•Provide advice and guidance for commercial and marketing team during preparation of promotional materials.
•Supports tender department and manage their technical requests in timely manner.
•Support with import permits and provide the regulatory input if required.
Communication & Coordination:
•Perform consistent and result oriented communication with Internal/ External stakeholders and distributors.
•Establish effective relationship with local distributors and HA key personals based on transparency, trust, and respect.
Pharmacovigilance Support.
•Support PV team member with PV SOPs Preparation.
•Collaborate with Pharmacovigilance team to monitor the safety and quality of registered and marketed medicinal products and detect any change to their risk-benefit balance.
Regulatory Due-Diligence:
•Collaborate with business development and perform Due-Diligence process for new business opportunities if required.
e-CTD:
• Preparation and life cycle management
•Regulatory submissions SFDA/GHC (New drugs, Generics multi-source, Health products, Herbal Products).
•Double-check the registration dossiers to make sure its compliance with SFDA/GHC requirements technically and administratively.
•Make sure that all submissions will pass phase I and phase II validation process without inquiries.
•Support principles with analytical requirements.
•Draft special import permissions.
•Planning and execution of GMP (SFDA/GHC) inspections visits for purpose of manufacturing sites approval/ renewals.
•Ensures maintenance of registered products in coordination with IRA and supply chain to make sure all shipments reached smoothly to Cigalah warehouses.
•Support principles in preparation and submission all CMC variations.
•Align all regulatory activities with principles standards and policies.
•Support principles Global RA with response to questions and provide exit door for all bottlenecks associated.
•Coordinate Patent search from KACST and GHC patent office.
•Request meetings with SFDA staff and prepare MOM.
•Support principles with all price issues including price appeal, re-pricing.
•Prepare and manage all needed exemptions in case basis.
•Coordinates submission and distribution of DHCPs.
•Cosmetics Manufactures and products registration.
•Manage 2nd Brand project under the name of Cigalah as MAH.
•Obtain and maintain warehouses license, manage storage for others licensing.
•Operate on major SFDA electronic services (DENR, SDR, e-SDR, E-Cosma, PCS, MDMA, MDNR, MDEL IBRCS )
•Supervise registration files preparation.
•Double check dossiers using country specific check list (MENA).
•Coordinate and manage supply of analytical requirements (Standards, Columns…).
•Main contact for all technical inquires; coordinate with QC and R&D for best response to questions.
•Training the subordinates and newly joined RA staff.
•Handling Sudan regulatory project for newly acquired site in Khartoum (Sigma-Tau)
• Quality Control testing for all dosage forms.
• In-process control for all dosage forms.
• Cleaning validation.
• Process validation.
• Raw Material Dispensing and analysis.
• Packaging material dispensing and Analysis
• Member of USP inspection preparation team.
• HPLC and Physical apparatus calibration.
Analytical chemistry