Medical Representative At GSK

Regulatory Affairs Section Head At GSK

Regulatory Affairs Section Head At GSK

Job Purpose

Provide support to ensure successful launch of new products and achievement of innovation targets.

Responsible for maintenance of CH products in order to ensure their viability on the market.

Ensure the compliance of all promotional activities for CH products.

Key Responsibilities:

Support New Product Registrations:

Support the regulatory team’s NPI projects by assisting with communication with Global RA regarding availability of documentation required for local submissions.

Assist with Customizing, preparing and submitting drug registration applications as requested by the respective Health Authorities in a timely manner.

Follow up through the evaluation phase to achieve a favourable outcome.

Maintenance of registered products:

Customize renewal files for local submissions, ensuring completion of missing docs until approval is secured.

Customize the global & local variation files, following up and tracking the variations applications until approval and coordinate with other countries sharing the same SKUs.

Respond to Health authorities’ requests and inquiries in alignment with senior team members.

Product Information and Artworks:

Maintain the local / country specific product information and consumer information, ensuring the correct distribution and use of the approved versions of these documents.

Update the Product & Consumer Information based on Global updates or local Regulatory authority regulations.

Review of Promotional Material:

Review promotional material for products in Egypt, Prepare & submit file of the promotional material to the Regulatory authority, coordinate between the Regulatory authority & the marketing department & follow up until the approval is obtained.

Secure timely approvals for Oral care & Medical device invoice importation clearance.

Provide monthly feedback on tasks, update the available databases, develop & implement new tracking tools for these activities whenever needed & Maintain efficient regulatory archive.

Update regulatory systems on regular basis.

Knowledge/ Education / Previous Experience Required:

Education and Experience:

Bachelor’s Degree in Pharmaceutical.

Excellent command of English language.

0-2 years of experience in Pharma Regulatory Affairs.

Essential Skills and Abilities:

Excellent computer skills (MS Office)

High business acumen

High communication & interpersonal skills

Organized & Structured

Work ethics and adherence to company values.

Accountability, Collaboration and Transparency.

Motivated, well organized with an analytical mind.

Action oriented & results driven.

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