Regulatory Affairs Specialist

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Job Description

Job Title Regulatory Affairs Specialist

Location Kyiv, Ukraine

About The Role

Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future in Takeda. Join us as a Regulatory Affairs Specialist.

Takeda is a global pharmaceutical leader with more than 31,000 professionals working together across 70 countries. We have an unwavering dedication to put people first and we live our values of Takeda-ism—Integrity, Fairness, Honesty, and Perseverance. We are united by our 235-year legacy of research-based pharmaceuticals and our mission to strive toward Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

How You Will Contribute

As Regulatory Affairs Specialist you will be responsible for Maintenance of Regulatory Activities.

Key Responsibilities

• Assess the dossiers for registrations, renewals, variations of the products in accordance with the Ukrainian, Moldavian and Belarusian legislation requirements.
• Maintain registration procedures (including, request of the documents, preparation of the documents for the submission, development of local documents, working with Regulatory Authority from submission to issuance of final approvals).
• Communicate with the global RA/manufacturers within satisfying additional requests and comments of the regulatory authorities.
• Perform GMP recognition procedures (including, request of documents, checking for compliance with the requirements of the Legislation, preparation of documents for submission, development of local documents, communication with government authorities).
• Collaborate with the internal stakeholders concerning the timelines of regulatory activities in order to insure uninterrupted supply of the products and launch of new products.
• Develop RA SOPs.
• Create and approve packaging materials.
  
  

Critical Skills And Competencies

• Co-operation and teamwork.
• Ability to proactively face and solve potential or actual problems.
• Attentive to details.
• Good internal and external communicator.
• Ability to deal with complexity.
• Results oriented.
• Sociability, systematic, attentiveness, punctuality.
• The ability to work under pressure and to strict deadlines
  
  

Experience And Education

What you bring to Takeda

• Ideally have at least 2 years of experience in the same position.
• Higher education (pharmaceutical, medical, biological).
• Knowledge of medicines registration legislation (Ukraine, Moldova, Belarus).
• Ability to build productive partnership with different external and internal stakeholders.
• Fluent Ukrainian and Russian, English not lower than Intermediate.
  
  

What Takeda Can Offer You

To further support and inspire our employees, our benefits include

• Corporate Flexible Benefits program (annual bonus, long term incentive)
• Meal allowance, flexible hours
• Comprehensive health and life insurance
• Exposure to working in an inclusive and diverse workforce
• Tremendous exposure and learning across a wide geography
• Training and Developmental opportunities
  
  

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, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Kiev, Ukraine

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time