Regulatory Affairs Lead and Scientific Office Manager - Egypt
Job Type: Full Time
Job Level: Senior
Travel: Minimal (if any)
Overview:
Takeda has been translating science into breakthrough medicines for 240 years. Our teams collaborate to tackle challenging problems in drug discovery and development. In R&D, we foster an environment welcoming diverse thought, amplifying every voice, and advancing transformative therapies that impact millions globally. Join a team that has earned trust for more than two centuries and shape a bright future.
Job Description:
Job Title: Regulatory Affairs Lead and Scientific Office Manager - Egypt
Location: Egypt
Accountabilities:
Collaborate with global/regional/area regulatory strategy to provide regulatory guidance to functional groups and management.
Lead licensing, marketing, and compliance efforts for registration files and regulatory assessments for changes impacting Takeda products.
Execute timely market applications, variations, renewals, post-approval reporting, and lifecycle management submissions.
Partner with cross-functional teams to develop strategic plans for new product launches and accelerate patient access.
Monitor regulatory environments and assess impacts of new or changing regulations in Egypt.
Ensure compliance of regulatory activities with Egyptian legislation and Takeda internal procedures.
Build team capabilities through regular coaching, mentoring, and development of Individual Development Plans (IDPs).
Prepare and review meeting materials, lead meetings with regulatory agencies, and participate in agency inspections as needed.
Support Egypt General Manager on legal projects, inspections, and scientific office responsibilities, including acting as responsible pharmacist for medical samples warehouse.
Participate actively as a member of Egypt’s leadership team and support governance activities.
Plan regulatory budgets and ensure OPEX spending aligns with approved MRP.
Ensure compliance of media and marketing materials with local regulations; maintain updated local product information.
Perform quarterly review of products listed in the Pharmacovigilance Master File and update regulatory databases.
Handle Egyptian Drug Authority (EDA) inspections and ensure scientific office compliance.
Education, Behavioural Competencies, and Skills:
Education & Experience:
Bachelor’s degree in Pharmacy from a reputable university.
MBA or postgraduate education in healthcare administration or health economics is an advantage.
7-10 years of regulatory experience in a medium to large organization; experience with biotech product registrations is advantageous.
Strong working knowledge of Egyptian pharmaceutical regulations; international experience is a plus.
Core Competencies:
Demonstrates strategic enterprise thinking to serve patients and build trust, reputation, and business.
Creates an inspiring environment that enables organizational progress.
Focuses on priorities that deliver superior results.
Elevates organizational capabilities for current and future needs.
Effective verbal and written communication of scientific and strategic concepts.
Business Skills and Knowledge:
Strong communication (verbal and written) skills.
Solid knowledge of regulatory processes and requirements.
Good understanding of the pharmaceutical industry and Takeda’s commercial business.
Excellent leadership, managerial, interpersonal, and relationship-building skills.
About Takeda:
Takeda is committed to transforming patient care through novel specialty pharmaceuticals and industry-leading patient support programs. As a Global Top Employer, Takeda fosters stimulating careers, encourages innovation, and champions excellence. We offer an inclusive, collaborative workplace united by our mission to deliver Better Health and a Brighter Future for people worldwide.
Locations:
Egypt
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full Time
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