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Regulatory Affairs Lead And Scientific Office Manager - Egypt

7-10 years
Not Disclosed
10 April 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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