Job Description
Job Title: Regulatory Affairs Lead and Scientific Office Manager - Egypt
Location: Egypt
ACCOUNTABILITIES:
- In collaboration with global/regional/area Regulatory strategy; provide regulatory strategies to the responsible functional groups and regulatory management.
- Primarily responsible as a leader to ensure the appropriate licensing, marketing, and compliance of the registration files and to provide regulatory assessment for any foreseen change impacting Takeda licensed products.
- Ensure market applications, variations, renewals, post approval reporting obligations and product life cycle management submissions are timeously executed.
- Collaborate with Cross functional teams in developing strategic plans to manage the new products launches and accelerate Patients' access as needed.
- Provide guidance and advice on regulatory environments and provide impact assessment of new and changing regulations/requirements in Egypt.
- Ensure compliance of regulatory activities in Egypt consistent with Country Legislations and Takeda's internal protocols and procedures.
- Build capabilities, ensuring development of regulatory team through regular coaching, mentoring and team's IDPs.
- Prepare (as required) and review meeting materials and chair/attend meetings with regulatory agencies and participate in agency inspections as required.
- Support Egypt General Manager in specific legal projects, Inspections and variations related to Scientific office and act as responsible pharmacist for medical samples warehouse.
- Member of Egypt leadership team, Participate and support in all topics and discussions raised in alignment with the approved governance.
- Plan Regulatory Budgets and ensure OPEX spending in alignment with approved MRP.
- Ensure Takeda' Media and Marketing Materials are in compliance with the local regulation and all local product information used locally are up to date.
- Perform Quarter review for List of Products annexed to the Pharmacovigilance Master file and update the Regulatory information management databases as needed.
- Handling EDA inspections on Takeda scientific office and ensure compliance with Local regulations.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education & Experience
- Bachelor's degree in pharmacy from Reputable university.
- MBA and/or post graduate education in health care administration or health economics is an advantage.
- 7-10 years regulatory experience in medium to large reputable organization. Experience in registrations of biotech product will be an advantage.
- Excellent working knowledge of pharmaceutical regulations as they relate to the region of responsibility.
- Working experience within Egypt, relevant knowledge of international regions is an advantage.
Core competencies
- Demonstrates strategic enterprise thinking to find innovative ways to serve patients, and build trust, reputation, and business.
- Creates the environment that inspires and enables people to move the organization forward.
- Focuses on the few priorities that matter most and delivers superior results.
- Elevates the capabilities of the organization for now and the future.
- Effective communication skills to present effectively, both verbally and in writing, scientific and strategic concepts.
Business skills and knowledge
- Communication (verbal and written) skills.
- Solid knowledge of Regulatory process and requirements.
- Good knowledge and understanding of the current pharmaceutical industry and Takeda's commercial business.
- Excellent leadership, managerial, interpersonal and relationship building skills.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.
Locations
Egypt
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Takeda Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.
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Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
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Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
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Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.
Takeda Insights
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What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts. Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives. Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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