Regulatory Affairs Specialist

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OBJECTIVES/PURPOSE:

• Responsible to execute optimal regulatory strategies aimed to deliver product approvals and/or life cycle management in accordance with the regulatory objectives of the local business to enable ultimate strategy and faster access to innovative medicines in Egypt and to ensure compliance with local regulations.
• Responsible for all communication with local health authorities for all regulatory Affairs & registration activities related to small molecules and biological products.
• Support in timely response to any inquires received from the local health authorities.
• Collaborate with distributers to support importation plans and shipments release.
• Handle registration analysis with National labs "Biological and Pharmaceutical" and secure required testing materials.

ACCOUNTABILITIES:

• Close follow-up with different sectors in EDA for all Takeda's ongoing applications and collaborate with global responsible team to resolve related review questions.
• Preparation and submission New Marketing authorization applications as per the Product type relevant regulations.
• Securing required regulatory fees as per the local regulations and its tracking and settlement as per internal agreed process.
• Prepare and submit Life Cycle Management dossiers and any post approval commitments or reporting obligations required for licenses maintenance.
• Maintain and track pricing licenses for renewal prior invalidation date.
• Timely submission of Labeling safety and non-safety updates within the due dates and deferral submissions as applicable.
• Follow-up with the national labs for Pharmaceutical and Biological products for Takeda products under Registration analysis.
• Databases maintenance and data entry verification for all regulatory information on Takeda's Regulatory information Managements systems "RIM" and electronic documents managements systems "EDMS".
• Maintenance of all local trackers supporting submissions, approvals and reporting intervals.
• Adhere to all internal company SOPs & processes to ensure compliance.
• Support cross functional teams in Media monitoring files submissions, approvals and release.

CORE ELEMENTS RELATED TO THIS ROLE:

• Regulatory compliance: Ensuring all activities, processes, products comply with relevant regulations and laws.
• Regulatory submissions: Preparing, compiling and submitting regulatory documents and dossiers.
• Labelling and packaging compliance; Ensuring that product labelling and packaging meet regulatory requirements.
• Quality Assurance: collaborating with QA team to ensure the products meet quality standards.
• Cross Functional Collaboration; collaborating with various departments at LOC and Global side to ensure smooth regulatory plan execution.
• Communcation health authorities by responding to inquiries, providing information when requested and follows up on the ongoing projects.
• Collaborate with distributers to support importation plans and shipments release.

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

• Experience in EDA latest regulations and Guidelines for both small molecules and Biologics.
• Understanding of national labs requirements and release process.
• Good knowledge in Media monitoring Regulations and Guidelines.
• Familiar with PV local requirements.

Interaction

• Ability to efficiently interact and negotiate with EDA different sectors.
• Ability to collaborate and communicate with Cross functional team on the local level.
• Ability to clearly communicate with global and regional teams via emails and in virtual meetings.

Complexity

• Handling both small molecules and Biologics (Egypt full portfolio, all Therapeutic areas)
• Interacting with all EDA sectors (Registration, Labs, inspection, Media monitoring)
• Capacity to understand complex systems

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor's degree in pharmacy from Reputable university.
• 5 years of regulatory experience in pharmaceutical regulatory affairs in a medium to large size reputable organization/s for pharmaceutical product.
• In depth understanding of EDA different regulations for both pharmaceutical, biological products, and Media monitoring regulations and CTD requirements.
• Fluent in Arabic and English key skills, abilities, and competencies:
• Pro-active, positive, open to learn, well organized, ability to prioritize tasks.
• Ability to work in a fast-paced environment with demonstrated ability to deal with competing tasks and demands.
• Effective communication, presentation, negotiation skills in order to present effectively, both verbally and in writing,
• Analytical skills and ability to raise potential issues with line manager to find effective solutions.
• Ability to drive multiple simultaneous projects, excellent time management and projects tracker.
• Details oriented individual with a ‘can do’ attitude and team collaboration
• IT- savvy and process orientation.

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Takeda is committed to providing a safe and healthy working environment and to having a workforce that is as diverse as the patients we serve and the communities where we’re based. To achieve that inclusivity, we embrace and celebrate our differences, respecting and valuing each other regardless of race, color, sex, age, national origin, religion, gender identity, sexual orientation, disability or physical appearance.

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