Regulatory Affairs Lead and Scientific Office Manager - Egypt

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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