דרושים » רפואה ופארמה » Regulatory Affaire Manager

משרות על המפה
 
בדיקת קורות חיים
אבחון און ליין
VIP
הפוך ללקוח VIP
רגע, משהו חסר!
נשאר לך להשלים רק עוד פרט אחד:
 
שירות זה פתוח ללקוחות VIP בלבד
AllJObs VIP
ל.י.א.ל כח אדם
Location: Ness Ziona
Job Type: Full Time
Manages the strategy, coordination, compilation and submission of new product applications, investigational new product applications and post approval supplements to the regulatory agencies.
Ensures compliance with global health authority regulations and interpretations. repares responses to regulatory agencies' questions and other correspondence.
Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
Provides solutions to a variety of problems of moderate scope and complexity. Organizes and maintains reporting schedules for new product application and investigational new product applications.
Leads and develops a team of regulatory affairs professionals in furtherance of the duties and responsibilities of
Requirements:
Minimum BSc in engineering, biological, pharmaceutical, or chemical sciences with advanced degree (i.e. Pharm.D or Ph.D) preferred
7+ years of relevant progressive experience in CMC / technical regulatory affairs.
5+ years of people leadership and management of direct reports
Demonstrated ability to communicate regulatory requirements clearly, accurately, and concisely.
Strong knowledge of global health authority laws, regulations, guidance and the regulation submission routes available for assigned products.
Experience developing regulatory strategies and an understanding of the product development process.
Expertise in product development and its application in global regulatory strategy.
Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical and/or biologic industry.
Experience leading interactions with health authorities under sup
 
Hide
5684127
שירות זה פתוח ללקוחות VIP בלבד
עדכון קורות החיים
לפני שליחה