Regulatory Affairs Specialist

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Job Title: Regulatory Affairs Specialist
Location: Kyiv, Ukraine

About the role:

Responsible for Maintenance of Regulatory Activities. Sociability, systematic, attentiveness, punctuality, the ability to work under pressure and to strict deadlines.

How you will contribute:

• Assess the dossiers for registrations, renewals, variations of the products in accordance with the Ukrainian 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.

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.

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.