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Regulatory specialist

50333
Regulatory specialist
г.Москва
Российская Федерация
Европа; Ближний Восток; Африка
Elanco

КОНТРАКТНАЯ ПОЗИЦИЯ - полная занятость


Position Description:
Responsible for maintain life cycle of existing product registrations and ensure in-time submission and approval of new products registrations and renewals. Has to ensure 100 % compliance of product registrations and packaging materials with regulations of local legislation.

Functions, Duties, Task:
  • To review and assess regulatory documentation prepared by global regulatory department for further submissions to local Regulatory Authorities;
  • Own interactions with Competent Authorities at all steps of product registration process , prepare dossier documents, arrange translation, complete registration dossiers for new products submissions in accordance with yearly registration plan , to ensure in-time receiving of approval documents;
  • To accomplish and ensure in-time submissions and approval of renewals and variations;
  • To arrange payment of local regulatory fees, to ensure import permits obtaining for registrations samples delivery;
  • To identify potential risks and gaps in the assigned projects and propose solutions to mitigate those;
  • Accountable for providing the most accurate and up-dated information about regulatory requirements in geography of responsibility in respond to any intra-company internal request
  • Deliver projects in time, whilst ensuring communication of status and requirements across multiple business functions, organize and hold regular calls and F2F meetings with involved function areas;
  • Ensure regulatory compliance of printed packaging materials
  • Prepare responses to official requests received from the Local Regulatory authorities;
  • To review and ensure compliance of local promotional materials;
  • Understand and act according to regulatory compliance and local policies, track and follow-up on any changes in regulatory requirements of CIS/RU
  • Ensure compliance with procedures and systems necessary to maintain proper regulatory records
  • Support other departments with RA information/communication

50333BR

Minimum Qualification (education, experience and/or training, required certifications):

§ University degree in pharmaceutical or medical sciences, with veterinary study preferred

§ English language - advanced written, fluent speaker

§ Good knowledge and understanding of local legislation in regulatory sphere

§ Experience of working in Regulatory Affairs in local either international company

Additional Preferences:

§ Positive attitude and fit with Elanco cultural pillars

§ Demonstrated experience in working effectively with teams and various functional areas

§ Accuracy and analytics mindset

§ Excellent organizational and implementation skills

§ Personal accountability and strong drive for execution

§ Ability to set priorities and manage multiple tasks.

Other Information:

§ Strong interpersonal and communication skills

§ Personal characteristics - pro-active, accurate , responsible, disciplined, precise

§ Minimal international business trips required

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