Regulatory Affairs Associate
Leosons International
Total years of experience :11 years, 2 Months
1)Looking after end-to-end management of regulatory affairs department as per schedule and ensuring timely completion & delivery of work to management
2)Knowledge on product registering across middle east, Africa & Asia for Conventional, GSL products and medical devices
3)Responsible for the preparation and submission of new product dossiers.
4)Maintained direct interactions and negotiations with Regulatory Authorities
5)Functioning with Business Development and Marketing to set suitable regulatory procedures on the short, medium and long term, thereby adding
novel product range to company’s portfolio.
6)Provide regulatory Input to product life cycle planning.
7)Continuous coordination with Regulatory agents and local distributors to make sure to meet the planned submission and approval dates.
8)Site registration activities in MENA countries.
1 Maintained direct interactions and negotiations with Regulatory Authorities (MOH UAE and Central Quality Control Lab)
2 Preparation, review and compile of complete Module-1 and 3 documents as per CTD format.
3 Collecting, Evaluating and Compiling of Module-3 documents like Specifications, STP, DMF, Validation of analytical methods and Stability Data.
4 Support design team with artwork development and ensure that the information on the patient information leaflets and on the packaging materials are according to current guidelines.
5 Coordination with the API suppliers to get all the required documents for registration & renewal of the products.
6 Respond to deficiency letters from authority (Drug registration department and Central Quality control lab) and co-ordination with different departments (like PDL, QC & QA) in order to fulfill the requirement.
7 Arranging all the required HPLC columns, reference standards, Impurities to the Central Quality Control Lab.
8 Preparation of new product dossiers, renewals as per the CTD format and Guidelines of various respective MENA region countries like Jordan and Sudan etc.,
9 Functioning with Business Development and Marketing to set suitable regulatory procedures on the short, medium and long term, thereby adding novel product range to company’s portfolio.
10 Provide regulatory Input to product lifecycle planning.
11 Continuous coordination with Regulatory agents and local distributors to make sure to meet the planned submission and approval dates.
12 Preparation and submission of variation files like additional pack size for different sterile products
13 Experience in Legalization of different documents like CPP, GMP and price certificates, authorization letters etc. etc., from MOH, Foreign Affairs & respective Country Embassy/ Consulate for registration and renewal purpose to different countries
14 Update RA procedures as needed to ensure company is in compliance with new and changing regulatory requirements.
15 Participated in Tender documentation like SGH
16 Allocation of GS1 codes to products
17 Application for DDC codes from DHA
18 Online application for import permits
Quality management system (QMS)
1 Handling Of Incidents
2 Handling Of Deviations (Planned And Unplanned)
3 Handling Of Change Controls
4 Risk Evaluation Using Quality Risk Management
5 Corrective Action And Preventive Actions (CAPA)
6 Handling Of Market Complaints
7 Mock Recalls
Audit and compliance
1 first party audits
2 second party audits
3 third party audits
SAP implementation
Training Activities
Calibrations and Validation Activities
Documentation Control Activities
