Regulatory Affairs Manager Abbott Laboratories

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

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 Partner s 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.

Responsible for LOT Release and Submitting the withdrawn product dossiers in NODCAR for analysis.