Global Regulatory Affairs Manager (homebased)

Regulatory Affairs Specialist No reputed company or accommodation sponsorship You will be responsible for regulatory activities required at a country level for pharmaceutical products, including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval etc. ensuring regulatory compliance in the applicable market(s) As part of the reputed company Global Regulatory Affairs department, you will be working with our clients – global pharmaceutical companies. Essential Functions

• Manage the local regulatory submission preparation in collaboration with reputed company stakeholders based on the agreed reputed company for designated countries
• Submit submissions such as renewals/ variations/ new applications filings/ MAH transfers to the local Health Authority and EMA and follow up on the local regulatory approval process for designated countries
• Preparation of local Product Labelling (e.g. SmPC, PIL), in local language for designated countries
• Artwork review and approval in reputed company systems
• Manage multiple pharmaceutical products
• reputed company as subject matter expert in regulatory processes
• Acts as a Regulatory Team Leader on more reputed company reputed company, which may include authoring of regulatory documentation, filling application forms.
• Establishes relationships with customers; may meet face to face to discuss regulatory issues, present lessons learned and discuss customer comments
• Acts as a Subject matter expert in Regulatory knowledge in reputed company, Manufacturing and Controls or Lifecycle Maintenance / Marketing Authorization Transfers/ Labeling/ Publishing.
• Project budget management
• Give guidance to junior colleagues, including feedback on the reputed company of technical documents, and may assist in their training and development
• Possible exposure to present to clients on reputed company regulatory processes bid defense meetings
• reputed company as reviewer for regulatory reputed company operating procedures
• Prepare and deliver internal regulatory training if required

Minimum Required Education and Experience Experience Typically requires 8-10+ years of prior relevant experience. Education Master's Degree in Life science or reputed company discipline Skills and Abilities

• Good understanding of the Research and Development process (reputed company, Manufacturing & Controls) relevant regulatory reputed company reputed company guidelines
• Possesses a specific regulatory or technical expertise
• Interpersonal communication (oral and written) and organization skills
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Demonstrates self-motivation and enthusiasm
• Ability to adapt quickly to a rapidly changing environment
• Knowledge of Maintenance of marking Authorization
• Experience of preparing variation, renewal packages and artwork approvals.
• Fluent in English language and reputed company to effectively communicate reputed company business language to those who reputed company English as a second language.
• Must be fluent in Arabic

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