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Regulatory Affairs Manager

Apply Now Email Me Job ID R0010722 Date posted 07/25/2019 Location: Kiev, Ukraine

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Job Description

Regulatory Affairs Manager

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 Regulatory Affairs Manager.

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.

Watch our Medicine for the World video.


Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.

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

KEY RESPONSIBILITIES:

  • Documentation/dossiers assessment against normative requirements, ensuring proper and timely communication on new and changed regulatory requirements to GRA and within organization
  • Participate in development and execute regulatory plans for new drugs and maintaining licenses/authorizations for the approved ones; provide sound regulatory decisions and justifications of any proposed regulatory strategy; potential regulatory risks assessment
  • Communicate with the global RA/manufacturers within satisfying additional requests and comments of the regulatory authorities
  • Ensuring effective Regulatory Health Authority interactions
  • Monitoring of applicable regulatory requirements
  • Negotiate with State Authority’s officials; follow-ups with the authorities regarding all regulatory matters in Ukraine, Moldova and Belarus
  • Perform constant checks of the product sheets, labels and regulatory tables; ensure that all documents and registrations comply with the Ukrainian, Moldavian and Belarusian regulations
  • 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 to insure uninterrupted supply of the products and launch of new products
  • Develop RA SOPs

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

  • 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

Empowering Our People to Shine
takedajobs.com

Locations

Kiev, Ukraine

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Apply Now Email Me