Regulatory Affairs Manager Egypt and Libya
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
