Regulatory Affairs Manager

JOB DESCRIPTION:

Job Title Regulatory Affairs Manager

About Abbott

Abbott is a global healthcare leader creating breakthrough science to improve peoples health. Were 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 worlds fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology womens health cardiometabolic pain management/central nervous system and respiratory.

As the DevOps Director youll 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. Youll manage operations collaborate with security and infrastructure and support IT defects.

What Youll Do:

Core Job Responsibilities:

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

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.

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

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

Monitor impact of changing regulations on submission strategies.

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

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

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

Ensure compliance with product post marketing approval requirements.

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

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

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.

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

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

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

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

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

Implement corrective/preventive actions as appropriate.

Raise awareness to relevant functions on compliance issues and initiatives.

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.

Ensure alignment and implementation of internal regulatory initiatives.

Identify and present option for risk mitigation to decision makers.

ResponsibleforLOTRelease andSubmitting thewithdrawnproductdossiersinNODCARforanalysis.

Required Qualifications

Bachelors degree of pharmaceutical sciences .
At least 7 years industry related experience in Regulatory Affairs.

Preferred Qualifications

Team working skills with special focus on results.
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:
Analytical problem solving and negotiation skills.
Good communication skills.
Project management skills.
Strong planning and priority setting.
Dynamic and flexible.
Problem solver.
Good capability to establish positive networking both internally.
Strong knowledge of quality systems.

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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The base pay for this position is

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

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