Regulatory Affairs Manager Egypt and Libya

Main Responsibilities:

Leadership & People Management

• Lead and mentor assigned member(s) of the regulatory team providing guidance coaching and professional development opportunities to build capability and ensure high performance.
• Foster a collaborative and supportive team culture ensuring alignment with business priorities and compliance standards.

Regulatory Strategy & Compliance

• Serve as the appointed Regulatory Lead for Allergan Aesthetics in Egypt managing the medical devices portfolio.
• Strategic member of Allergan Aesthetics extended management team.
• Regulatory Affairs Lead for Libya represent RA in Libya brand teams and working cross function to ensure business sustainability in Libya
• Define and implement regulatory strategies for Egypt and Libya aligning local needs with Global/Area regulatory strategies to support product launches and life-cycle management.
• Support the preparation review and submission of regulatory dossiers renewals variations and notifications ensuring timely approvals and ongoing compliance.
• Manage interactions with local health authorities maintaining effective relationships to secure timely approvals resolve queries and ensure compliance with registration vigilance inspection and pricing requirements.
• Monitor and assess emerging regulatory legislation (local and international) and communicate potential business impacts.

Product & Portfolio Support

• Drive & support the registration and maintenance of complex applications and new product submissions ensuring compliance with relevant legislation and company requirements.
• Ensure accuracy and compliance of prescribing information labeling and promotional materials in line with company policies and local regulations.
• Coordinate packaging and labeling projects with QA and third-party partners ensuring timely implementation of artwork updates.
• Collaborate with marketing and demand planning teams to provide regulatory input into business cases and launch plans.
• Contribute to strategic brand and cross-functional discussions supporting business growth and patient access.

Regulatory Excellence

• Cooperate and liaise with manufacturing sites corporate headquarters and cross-functional teams across Egypt Libya.
• Represent AbbVie in relevant pharmaceutical trade associations and engage with external stakeholders to influence regulatory environments.
• Build and sustain strong relationships with regulatory institutions across the region.
• Identify and track changes/trends in regulatory practices and attitudes sharing insights with internal stakeholders to support proactive decision-making.
• Drive excellence and effectiveness of the Regulatory Affairs function ensuring support for NPI and launch excellence within the region.

Compliance & Training

• Ensure compliance with AbbVies corporate policies procedures and local regulations to meet statutory quality and business requirements.
• Serve as the support function for regulatory training initiatives and other regulatory-related activities within Egypt/Libya.

Transforming the Organization:

• Participate in brand teams to provide regulatory input into product development and project planning ensuring alignment with regulatory requirements throughout.
• Support business development opportunities in the market by providing regulatory insight and expertise.
• Coordinate cross-functional support for sales marketing product complaints medical queries and customer information.

Governance & Representation

• Maintain accurate records of all regulatory submissions approvals and authority correspondence.
• Represent AbbVie in national regulatory taskforces and local trade associations advocating for company and industry interests.

Qualifications :

• Strong leadership and people management skills with proven ability to mentor and develop regulatory professionals.
• Demonstrated sound judgment strong communication and effective negotiation skills with internal and external stakeholders.
• Excellent teamwork and cross-functional collaboration capabilities.
• Highly developed project management skills with the ability to manage complex regulatory initiatives.
• Minimum of 10 years experience in Regulatory Affairs within the healthcare/pharmaceutical industry ideally in multinational or affiliate organizations.
• Comprehensive knowledge of EU US and Egypt/Libya regulatory frameworks and pharmacovigilance requirements.
• Fluency in English (written and verbal) with strong communication skills.
• Proficiency in computer applications and digital tools to support regulatory operations.

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time