Senior Regulatory Affairs Specialist (outstaff, one year)

Senior Regulatory Affairs Specialist (outstaff, one year)

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 at Takeda. Join us as Senior 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.

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

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

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:

• 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

Empowering Our People to Shine

takedajobs.com