28 days old
50333
Regulatory specialist
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; ;
Elanco

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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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Apply Later

Categories

Industry

  • Science
Posted: 2019-06-17 Expires: 2019-07-18

As one of the oldest continuously operating companies in the United States, we are proud of all the innovative work we’ve accomplished for the last 140 years to improve global health.

We are looking forward to an even more successful future in which continued innovation and contributions from top talent in all areas of our organization will be critical.

Are you looking for a way to make life better for people around the world? We have opportunities in many areas of our organization. Please use the search feature to see the wide scope of our positions.

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