Head of Regulatory

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Job Description

PURPOSE OF JOB 
The Head of Regulatory is responsible for overseeing the entire product registration process within the assigned region to ensure uninterrupted patient access to therapy. 

DUTIES 

•    Provides operational leadership on all matters related to the timely state registration of the company’s products, as well as the renewal of registrations and amendments to regulatory documents, including updates in compliance with EAEU legislation. 
•    Develops and implements regulatory strategies to ensure the successful GMP (Good Manufacturing Practice) inspection of the company’s production sites and those of partner companies. 
•    Ensures the creation of standard operating procedures (SOPs). 
•    Monitors relevant regulatory legislation, identifies trends and potential changes, and adjusts work plans accordingly. 
•    Manages changes and risks in regulatory processes. 
•    Leads comprehensive cross-functional projects. 
•    Personally adheres to and ensures compliance within the area of responsibility with Russian legislation, ethical business practices adopted by the company and the industry, and business etiquette rules. 
•    Ensures effective team management. 

KNOWLEDGE, SKILLS AND COMPETENCES

•    Knowledge of current pharmaceutical industry regulatory legislation and development trends. 
•    Strong expertise in preparing documentation for submission to regulatory authorities. 
•    Understanding of the competitive landscape in the company’s areas of operation within the pharmaceutical market. 
•    Building and maintaining strong relationships, fostering trust with key opinion leaders, independent medical experts, and company partners. 
•    Strategic and entrepreneurial thinking to identify new ways to meet patient needs and achieve results. 
•    Creating an environment that inspires and motivates employees to drive the company’s success. 
•    Developing the next generation of leaders to sustain the company’s competitiveness. 

EDUCATION AND EXPERIENCE 

•    Extensive experience in medicines registration within a biopharmaceutical company, including the preparation of documentation for submission to regulatory authorities and successful engagement with regulatory bodies. 
•    Over 5 years of managerial experience in the field of drug registration. 
•    Higher education in pharmacy, chemistry, or medicine. 
•    A PhD or Doctorate in pharmaceutical, chemical, or medical sciences. 
•    Fluency in English. 

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