Regulatory Affairs Manager

European pharmaceutical company is looking for Regulatory Affairs Manager.

Responsibilities

• Coordinate and oversee regulatory activities to implement regulatory filings as required to support business objectives and the overall compliance.

• Ensure the development, implementation and compliance of relevant SOPs for Regulatory Affairs. This includes contribution to improve RA processes at regional and local level.

• Participate in global/regional projects.

• Assess registration dossiers and variation packages at regional level.

• Keep current with the local and international medical/pharmaceutical legislation and operation procedures.

• Provide training to RA personnel and answer questions relating to global and regional processes

• Supporting of Quality local system

• Conducting a procedure for confirmation of compliance of manufacturing conditions of medicines to GMP requirements in Ukraine.

• Work with instructions, preparation and approval of AW

• Prepare monthly reports for accomplishments, ongoing projects and future submissions.

• Corporate coordination of PV procedures between HQs and LCP, acting LSO for Ukraine

Requirements

• Bachelor in Health Science, Medical or Pharmaceutical education is preferable

• At least 3 years of regional regulatory affairs experience.

• Knowledge of international guidelines and national legislation related to drug registration and Pharmacovigilance.

• Capable of developing and implementing regulatory strategy from A to Z.

• Proficiency in English, good speaking level.

• Capability to prioritize tasks and be able to act as an independent manager fully responsible for Regulatory part of business.