Regulatory Affairs And Quality Assurance Manager

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking forward, anticipating changes in medical science and technology.

Working at Abbott

At Abbott you can Do Work That Matters, Grow, And Learn, Care For Yourself And Family, Be Your True Self And Live a Full Life.

• Career development with an international company where you can grow the career you dream of.
• A company recognised as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognised as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
• Potential future job opportunity at Abbott.

About Established Pharmaceuticals

We are committed to bringing the benefits of our trusted medicines to more people in the world's fastest-growing countries. Our broad portfolio of high quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management / central nervous system, and respiratory.

Regulatory Affairs & Quality Assurance Manager

What You'll Do

• Follow up on regulatory activities and plans for the assigned countries, renewal registration, registration, variation changes, safety issues, pricing, labelling and site transfers.
• Responsible for preparation of submission dossiers according to country specific requirements and regulations.
• Coordinate and align all country specific regulatory and registration requirements.
• Provide regulatory support for tender business.
• Respond to agency questions and develop/ coordinate appropriate responses.
• Initiate the pricing documents based on each country's needs.
• Develop and create new labelling printout according to countries regulations for core products without disruption.
• Communicate the updated patient information leaflet.
• Gather supporting information, coordinate and submit interactions with health authorities throughout the lifecycle of products.
• Ensure that registration files are complete and include all necessary documents for quicker submission and approval.
• Provide guidance to peers and external partners.
• Coordinate regulatory organisation processes with different partners in different countries.
• Communicate efficiently with all business partners and employees.
• Handle health authority queries.
• Review and approve promotional materials based on Abbott procedures and health authority regulations.
• Communicate local regulations by following the process of navigating changes and regulations.

JD & Organograms

• Maintain JD of the RA teams & line managers & upload on system.

RA Training Reports

Coordinate and ensure 100% completion within the due date.

Product List Maintenance

• Ensure maintaining the local product list updated.
• Follow the documented process (SOP & Work Instructions) on the local product list:
• Update/distribute within & out of the affiliate as well.
• Timely access.
• System archiving.
• Ensure information stated in the product list aligns to system (same validity dates, product info, registration number, etc.).

Local Operating Licences

• Local licences / GMP / proof of establishment / licence to operate.

Regulatory SOP & Procedure Tracking

• Ensure review of local SOP/working instructions and accuracy of the content covering all RA activities.
• Ensure use of updated templates and record versions, implementation & review dates.

Regulatory Submission Management

• Review global/regional & local related SOPs to support RA NPI/LCM and secure proper tracking & monitoring.
• Ensure proper monitoring of execution.
• Follow process for communication on submissions/ approvals.

Change Control & Regulatory Intelligence

• Review global/regional & local related SOPs to support HA communication/commitment & queries.
• Global/local process for review & sign off of health authority communication & commitment, timely tracking & monitoring.
• Review process of promotional material and advertising control and approval.
• Review local related SOPs and regulations for promotion material & advertisement control.
• Document proper review, sign off and implementation monitoring by Abbott and its agents.

Risk Management Plan Submissions

• Follow process, tracking & monitoring as per the mandate of Global SOP.

CAPA Management

• Secure previous audits CAPA (QA/PV etc) to ensure closure/on track.
• Ensure with local QA that any deviation to local/global SOP is properly managed by a deviation.

Archiving & Handover Processes

• Review & tracking process of archiving (global & local products).
• Review & tracking process of handover (global & local products).
• Review and tracking process for RA/PV reconciliation.
• Dossier archiving on system; check all product portfolio has a registered position built on system.

Training

• Qualified as trainer for training on local procedure.

Project Coordination

• Liaise with stakeholders to define project requirements, scope, and objectives.
• Break projects into doable actions and set timeframes.
• Assign tasks to internal teams and assist with schedule management.
• Work with the project lead to eliminate blockers.
• Monitor project progress and handle any issues that arise.
• Help prepare P&L statements.
• Analyse risks and opportunities.
• Act as point of contact and communicate project status to all participants.

Quality Assurance Responsibilities

Written procedures must be established and maintained for a quality system at the affiliate level to ensure compliance with applicable regulations and conformance to specified product requirements. CDQA must incorporate Abbott policies into their quality system. CDQA must have the authority to approve or reject all affiliate quality related documents and records to assure that no errors have occurred or, if errors have occurred, that they have been appropriately investigated.

Management Review

• Management reviews must be conducted quarterly; additional reviews can be performed at any time during the year if necessary.
• Minimum requirements are defined in COMM.01.01.SOP.

Quality Manual & Audit Program

• A quality manual must be established and maintained to state how the Abbott Quality System is implemented at the GEM & LEVANT affiliate.
• A quality audit program must be established and maintained to independently appraise and oversee the quality systems, including audit readiness, internal self inspection and external supplier audits.

Complaints Handling

• Non medical and medical complaints with potential quality implications, including review of all received non medical product complaints open/aging status and analysis based on complaint criticality.
• Management of products' related non conformance and deviation.

Quality Events Handling

• Ensure procedures for deviations, non conformities are implemented and maintained.

Product Actions

• Significant events.
• Counterfeiting, tampering, diversion and product theft.
• Situations for corrective and preventive actions.

Material Control, Cold Chain, Geo Expansion

• Ensure procedures for material control, cold chain, and geographical expansion of EPD products are implemented and maintained.
• Guarantee all minimum product and site quality and compliance requirements are met before release of the first lot through the FLQR process.

Risk Management, Supplier Management & Cyber Security

• Use risk management tools in different parts of the quality system to provide consistent and effective outcomes.
• Ensure procedures for supplier management are implemented and maintained.
• Support cyber security projects and initiatives.

Required Qualifications

Bachelor's degree with 8-10 years of relevant experience in a similar role within the pharmaceutical industry.

Equal Opportunity Statement

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Job Details

Role Level: Mid Level Work Type: Full Time Country: United Arab Emirates (Dubai) Company Website: Job Function: Quality Assurance & Control
Sector: Hospitals and Health Care