Regulatory Affair Manager

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.

We believe that diversity is the driving force behind innovation, creativity, and overall business success.

Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Position Title:

Regulatory Affair Manager

Position Description:

To conduct regulatory tasks for Korea by ensuring compliance with the appropriate regulations and guidelines and by being the interface between the company and the regulatory authorities for the existing product portfolio.  Also, to provide regulatory support to the Korea affiliate to ensure that existing product registrations are maintained and deliver all new product registrations for business growth.

This position will report to Korea Regulatory Affair Team Head.

Functions, Duties, Tasks:


* Independently take overall responsibility of multiple products/projects and set up an optimal local registration plan/registration strategy including local clinical trial application assigned by supervisor


* Handle requirements of regulatory authorities and Ensure to achieve responsible products/projects in timely manner.


* Maintain up-to-date all internal regulatory system and follow required processes



* Establish and maintain general understanding and knowledge of regulatory requirements, regulatory affairs SOPs and other functional systems.


* Deliver local requirements, registration strategy and timeline to within RA team and internal stakeholders (affiliate business units, Quality, Production, Supply Chain, GRA etc) in a timely and persuasive manner and draw support from internal stakeholders.


* Manage all the process of local clinical studies (if required) to ensure achievement of product registration.


* Regularly communicate with regulatory authorities/associations and participate in external RA activities network with APQA, KAHPA, MFDS, Universities and other industry colleagues.


* Monitor routinely the regulatory environment and assess the impact or risk of regulatory issues & changes to implement in a timely manner or spread out to the responsible dept.

if necessary.


* Provide required regulatory services (export business, GMP maintenance, PS support) and information to internal stakeholders to comply with local regulations & legal requiremen...