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accountant
fresher
driver
receptionist
digital marketing
part time
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الشارقة
Dubai
Abu Dhabi
Sharjah
دبي
أبو ظبي
Ras Al Khaimah
Fujairah City
الفجيرة
Ajman
رأس الخيمة
أم القيوين
تقديم

Regulatory Affairs & Quality Assurance Manager

Abbott
دوام كامل
منذ 3 أسابيع

     

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:

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 :

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)

Local Operating licenses detailed roles & responsibilities & System archiving:

Review & tracking process of Local RA SOP & procedures:

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

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

RA Risk Management Plan submissions management & tracking on system:

Change Control Management

CAPA management:

Other:

Training:

Project coordination:

Quality Assurance Responsibilities/ GEM & LEVANT

Quality System:

Management Review:

Quality Manual:

Quality Audit Program- Certified Auditor:

Audit Readiness:

 

Complaints Handling:

Quality Events Handling:

Product Actions

QA Holds:

Material Control:

Cold Chain Procedure:

Geo-Expansion:

Risk Management:

Supplier Management:

Cyber Security:

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

N/A

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

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

EPD Established Pharma

        

LOCATION:

United Arab Emirates > Dubai : Dubai Airport Freezone, Building 5WA, Floor 8

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

     

     

     

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