Regulatory Compliance and Technical Bid Manager
Intertek International Limited
مجموع سنوات الخبرة :18 years, 4 أشهر
Tender/Bid Submission and Registration Application
a. Involve in all stages of the preparation and management of submissions of tender/bid documents and application as Notified Body (NB), Conformity Assessment Body (CAB) and Cargo Surveying Company
b. Detailed review of Tender documents - Analysis of key documents/activities to be undertaken to enable the production of a compliant bid or NB or CAB application.
c. Identifying the main risks/opportunities of the project.
d. Attends any pre-tender meeting session and/or prepare and submit a letter to the tendering body to clarify any uncertainties or specific points in the RFT/RFP/EoI
e. Review, edit, write/coordinate the writing of material for tender/bid document
f. Produce tender/bid or pre-qualification document in order to achieve submission deadlines
g. Continued activity and responsibility to raise the standard and quality of company’s qualification documents to increase bid win ratio
Regulatory Compliance and Main Contact Person for ESMA (Federal UAE Authority)
a. Act as the primary contact person of the company for ESMA
b. Actively attends and participate in monthly regular meeting and trade exhibition with ESMA
c. Keeping up to date with changes in regulatory legislation and guidelines in the UAE
d. Assist with the preparation, draft and update of guidelines, forms, checklists and other related policies and documents related to the UAE ECAS and EQM Programme
e. Provides staff training related to UAE ECAS/EQM Programme
f. Monitor the team to meet the KPI target set by ESMA
g. Ensures correct and timely issuance of certificates in relation to the productivity and quality targets set by ESMA
h. Provides timely and effective responses to global offices and laboratories in relation to inquiries concerning essential product requirements, standards, and other service request inquiries for products regulated in the UAE
i. Performs technical review of cosmetics and perfumery application (e.g. Assessment of cosmetic ingredients/raw materials/finished products, etc.)
j. Assist clients with the registration of products with other local government authorities in the UAE (such as cosmetic and perfumery products in Dubai Municipality and ESMA; medical devices in the Ministry of Health; and other regulated products in ESMA, etc.)
k. Performs duties or other responsibilities which may be assigned by the Management such as drafting of flyers, attend to client’s online request, preparation and update of quality documents, factory audits, laboratory witness testing, etc.
Others
a. Produce consistently high-quality submissions and application package that are aligned with the corporate branding guidelines
b. Improve and provide creative and powerful Word or PowerPoint support and sales materials
• Undertake all general activities for collection and submission of applications and approvals with the Ministry and appropriate Government bodies in matters relating to the setup of product license and registration.
a. Prepare and complete required documentation for registration of products in line with Ministerial requirements.
b. Provide complete documentation, including translation of product description from English to Arabic.
c. Liaise where needed with the home and regional brand teams to obtain the relevant documents. Prepare submit and follow up on documentation.
• Set up the Product Brands Licenses.
a. Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
b. Develop procedures to ensure regularity compliance.
c. Prepare and submit all of the necessary documentation for the license to allow timely openings.
d. Handle Ministry inspections for license and set up and resolve any issues.
• Advise store on regulatory standards and implementation.
a. Provide a point of contact for Store/Ministry queries regarding product registration and issues.
b. Provide support for the Brand and Ministry inspectors and resolve any issue or non-conformity raised.
• Represent the Company at the Governmental Ministries, Departments and Customs Authorities
a. Always maintain a presentable and professional image of the company in all aspects.
b. Act as the primary point of contact for day to day Ministry issues.
• Pharmacovigilance
a. Prepare regulatory policies, development of protocols, SOPs and all related duties to enable PV workflow and activities.
• Market Surveillance Project Activity
a. Manage project development from initiation phase to closure of contract
b. Provide a project schedule to identify when each task will be performed and clearly communicate expectations and act as a mediator between team members
c. Resolve any issues and solve problems throughout project life cycle
d. Develop methods to monitor project or area progress and provide corrective supervision, if necessary, while ensuring that any changes to scope are documented and approved
• Tender Bid Activity
a. Involve in all stages of the preparation and management of entire bid submissions.
b. Direct liaison with internal offices to collate data information required for CVs, facilities, experience, certificates, journals, pictures and other "dramatic evidences" and forms.
c. Assess and anticipate market trends, technological developments, as well as customer and competitor activities
d. Maintaining a tender library with relevant company information and bid material for use in future tenders
• Regulatory Compliance Activity
a. Serves as a primary company contact for all international trade compliance-related activities and programme inquiries for countries of exports such as Algeria, Bangladesh, Botswana, Egypt, Ghana, Guinea, Ivory Coast, Kenya, Kuwait, Niger, Nigeria, Qatar, Russia, Saudi Arabia, Tanzania and Uganda.
b. Assessment of products’ conformance in line with international and national codes and mandatory Customs requirements like ISO, EN, IEC, CODEX, BS, GSO, SASO, KSS, KS, US, TZ, etc.
c. Perform site inspection, evaluation and approval of ISO/IEC 17025 accredited laboratories required for consignment testing works required for the Conformity Assessment Programmes (CAPs).
d. Generates case studies highlighting the success of the company's operation of CAP.
e. Keep abreast of changes in government trade regulations and legislation to keep all corporate compliance documentations, internal intranet and external websites accurate and up to date.
f. Develop effective global policies and procedures applicable to CAP operation.
g. Responsible for the finalization and release of the corporate trade compliance programme guidelines, site inspector’s guidelines, laboratory approval policies, certification procedures, etc.
h. Provides reports on a regular basis, and as directed or requested, to keep the senior management and governmental institutions informed of the operation and progress of the company's compliance efforts.
i. Develop and manage product classification database that would determine their regulatory status thru HS Code and ICS Code.
j. Prepare SQN reports on any national standard clausal requirements which are contradictory to international standards requirements.
k. Prepare quality documents when requested
• Ensures that Good Manufacturing Practices are observed inside the plant
• Perform line clearance activities in manufacturing and packaging areas (Plant sanitation, Staff hygiene, Equipment sterility, etc.)
• Conduct toxicological research, review and test and Retention for Track Recording
• Perform routine sampling and inspection functions for purchased raw materials, in-process products, pure drug substances, finished pharmaceutical preparations and packaging components
• Oversees product deviations and failure investigations:
• Approves or rejects the acceptance of tested raw materials and finished goods
• If discrepancy occurs, coordinates with concerned inputs regarding any deviations from set standards, participates in non-compliance investigations and recommend additional testing if necessary
• Maintain records of all analysis information of assigned products on data sheets for permanent file and proper entry of information on laboratory forms
• Knowledge of basic laboratory and production equipment including but not limited to: autoclaves, incubators, Karl-Fisher, chromatography (GC, LC) and spectrometry (IR, AAS)
• Perform laboratory and manufacturing audits, as required
• Perform equipment maintenance and calibrations, as required
• Implementation of SOPs for QA and QC division
• Final Product for Market Sale Analysis and Surveillance
RESEARCH EXPERIENCE. BENEFICIAL IMPACT OF AIR POLLUTION. The aim of this study was to develop and produce anti-bacterial sulphur soap from human hair that are highly exposed from air pollution.