Regulatory Affairs & Quality Assurance Manager

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, 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. You will have access to:

• Career development with an international company where you can grow the career you dream of.

• A company recognized 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 recognized 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-

Regulatory Responsibilities/ GEM & LEVANT

• 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

• Responsibilities will include different country requirements and tasks falling under the umbrella of regulatory for pharmaceutical products, coordinate and align all country's specific regulatory and registration requirements

1. Provide regulatory support based for tender business

2. Respond to agency questions and develops/coordinates appropriate responses.

3. Initiate the pricing documents based on each country's needs.

4. Develop and create new labelling printout according to country's regulations for our core products without any disruption of the existence of these products. 5. Communicate the updated patient Information Leaflet.

• Gather supporting information, coordinate and submit Interaction with health authorities throughout the lifecycle of products

• Ensure that registration files are put together and include all necessary documents for quicker submission and approval

• Provide guidance to peers and other external partners.

• Coordinate Regulatory organization 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 & uploaded on system

RA Training reports: Coordinate and ensure 100% completion within the due date

Review & tracking process of Product list Maintenance (all archiving should be on system)

• Ensure maintaining the local product list updated

• Ensure following the documented process (SOP & Work Instructions) on the local product list:

  • Update/ distribute within & out of the affiliate as well as

  • Timely access

  • System Archiving

• Ensure Information stated in the product list should be aligned to system (same validity dates, product info, registration number …) 

Local Operating licenses detailed roles & responsibilities & System archiving:

• Local licenses/ GMP/ proof of establishment/ license to operate

Review & tracking process of Local RA SOP & procedures:

• Ensure review of local SOP / Working Instructions and accuracy of the content that covers all the RA activities

• Ensure of the use of the updates templates and make sure the versions, implementation & review dates. 

Review & tracking process of Regulatory submission (NPI&LCM) management & system update + Review & tracking process of RA submission/ updates communication to Cross

• Review (global/regional & local) related SOPs to support your RA NPI/ LCM & Secure Proper tracking & monitoring

• Ensure a proper monitoring for the execution

• Ensure following process for communication on submissions/ approvals

Review & tracking Change control process & Monitoring  

Review & tracking process of Regulatory Intelligence Management + Review and tracking process for Health Authority updates/ regulation updates & Monitoring Review & tracking process of HA communication + HA queries and deficiency letters & HA commitment management (global & local products)

Review (global/regional & local) related SOPs to support HA communication/ commitment & queries Global/ local process for review & sign off Health Authority communication & commitment timely tracking  & monitoring

• Review & tracking process of promotional material and advertising control and approval process

• Review local related SOPs to support Promo material & advertisement control

• Review and provide ensure following the regulation supporting the local SOP

• Ensure & document a proper review/ sign off and implementation monitoring by Abbott and its agents (as applicable)

RA Risk Management Plan submissions management & tracking on system:

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

Change Control Management

CAPA management:

• Secure the previous Audits CAPA  (QA/PV…etc) ensure closed / on track

• Ensure with local QA that any deviation to local/ Global SOP is properly managed by a deviation. 

Other:

• Review & tracking process of Archiving process (global & local products)

• Review & tracking process of Handover process (global & local products)

• Review and tracking process for RA/PV reconciliation process.

• Dossiers Archiving on System, kindly check if all your products portfolio have registered position built on System.

Training:

• Qualified as trainer for training on local procedure.

Project coordination:

• Liaising 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 the point of contact and communicate project status to all participants.

Quality Assurance Responsibilities/ GEM & LEVANT

Quality System:

• 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 responsible must incorporate the system requirements defined in Abbott policies into their quality system.

• Quality Organization Responsibilities and Authority:

• CDQA must have the responsibility and 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.

  The responsibility for product and material release is defined as per local requirement.

  Legally responsible for release of goods if defined in the Quality/Technical agreement.

  This quality authority should not be delegated to other functions.

Management Review:

• Management Reviews must be conducted quarterly, however Additional Management Reviews can be performed at any time during the year, if necessary.

• For minimum Requirements, please refer to COMM.01.01.SOP

Quality Manual:

• A quality manual must be established and maintained and State how the Abbott Quality System is implemented at the GEM & LEVANT affiliate.

Quality Audit Program- Certified Auditor:

• A quality audit program must be established and maintained to independently appraise and oversee that the quality systems, including:

Audit Readiness:

• Abbott internal systems - Self inspection.

• External suppliers of materials and services

• GEM & LEVANT Commercial &Distribution QA to notify Region QA by any external audit and to ensure the procedure is implemented

Complaints Handling:

• Non-medical complaints and medical complaints with potential quality implications including a 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:

• It is the responsibility of the GEM & LEVANT Commercial and Distribution QA to ensure the procedure is implemented and maintained for the following:

• Exceptions, e.g., deviations, nonconformities

Product Actions

QA Holds:

• Significant events

• Counterfeiting, Tampering, Diversion and Product Theft

• Situations Corrective and preventive actions.

Material Control:

• It is the responsibility of the affiliate Commercial and Distribution QA to ensure the procedure is implemented and maintained.

Cold Chain Procedure:

• It is the responsibility of the GEM & LEVANT Commercial and Distribution QA to ensure the procedure is implemented and maintained.

Geo-Expansion:

• It is the responsibility of the GEM & LEVANT Commercial and Distribution QA to ensure Process related to Geographical Expansion of EPD products is being followed and guarantee that all the minimum product and site quality and compliance requirements are met prior to release of the first lot of a product to the market through First Lot Quality Review (FLQR) process

Risk Management:

• Use risk management tools in different parts of the quality system to provide consistent and effective outcome

Supplier Management:

• It is the responsibility of the GEM & LEVANT Commercial and Distribution QA to ensure the procedure is implemented and maintained.

Cyber Security:

• Support cybersecurity projects and initiatives.

Required Qualifications-

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

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

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