Regulatory Affairs Manager

Job Description

Job Title Regulatory Affairs Manager

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.

The Opportunity

This position works out of our [insert location of working site] in the Established Pharmaceutical Division where 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.

As the DevOps Director, you'll have the chance to lead a group of engineers to build code for the mobile and Web Cloud platform, working closely with product manager, customer support and testing teams. You'll manage operations, collaborate with security and infrastructure, and support IT defects.

What You'll Do:

Core Job Responsibilities:

• Collaborate with Partners to ensure timely and clear dossier requirements are provided to Egypt Affiliate during submission planning

u2022 Liaise cross-functionally to agree on submission strategy for new products, new indications, renewals and source changes/adds

• Ensures rapid and timely approval on of new drugs &biologics and continued approved status of marketed products or medical devices.

u2022 Ensure submission plans are created and maintained in Abbott Regulatory IT tools.

u2022 Facilitate implementation of the Regulatory Plan in alignment with the business plans.

u2022 Monitor impact of changing regulations on submission strategies.

u2022 Negotiate with regulatory authorities during the development and review process to ensure submission approval.

u2022 Maintain importation plan and align cross functionally on any possible risks.

u2022 Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.

u2022 Ensure compliance with product post marketing approval requirements.

u2022 Review and approve advertising and promotional items to ensure regulatory compliance.

u2022 Work cross-functionally to obtain all required submission documents and ensure timely responses to Regulatory Authority requests received.

u2022 Voice Region and Partner perspective and requirements to global regulatory contacts. Coordinate feedback to ensure documents are as required by Partner and use regulatory expertise to provide creative solutions/alternatives in cases where Abbott is unable to meet requirements.

u2022 Document submission plans and follow-up on progress of submission/timelines with assigned Partner(s) and periodically review with Partner's performance metrics.

u2022 Serve as affiliate regulatory point person for queries from the business or global functions (GRA, Quality, Supply Chain, Manufacturing) Regulatory Compliance.

u2022 Ensure data maintenance and data integrity of internal Regulatory IT tools with defined compliance metrics.

u2022 Ensure implementation of local quality system in line with the global quality system and local regulations.

u2022 Support internal and external audits / assessments / self-inspections in collaboration with Quality personnel.

u2022 Implement corrective/preventive actions as appropriate.

u2022 Raise awareness to relevant functions on compliance issues and initiatives.

u2022 Ensure timely creation of labelling projects in Agile and liaise with Medical, commercial, quality, Supply Chain and Opx to ensure new/revised labelling available in line with the business plan. Manage submissions and approvals for all labelling updates.

u2022 Ensure alignment and implementation of internal regulatory initiatives.

u2022 Identify and present option for risk mitigation to decision makers.

u2022 ResponsibleforLOTRelease andSubmitting thewithdrawnproductdossiersinNODCARforanalysis.

Required Qualifications

u2022 Bachelor's degree of pharmaceutical sciences .
u2022 At least 7 years industry related experience in Regulatory Affairs.

Preferred Qualifications

u2022 Team working skills with special focus on results.
u2022 Ability to adapt to challenging situations.

• Biological / Biosimilar registration experience.
• Demonstrated good computer/IT skills.
• Good knowledge of written and spoken English & Arabic.

Other Information/Additional Preferences:
u2022 Analytical, problem solving and negotiation skills.
u2022 Good communication skills.
u2022 Project management skills.
u2022 Strong planning and priority setting.
u2022 Dynamic and flexible.
u2022 Problem solver.
u2022 Good capability to establish positive networking both internally.
u2022 Strong knowledge of quality systems.

u2022 Trained on Abbott Regulatory IT tools.

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.

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