- 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 requirements.
- Review marketing / promotional materials in compliance with local regulation.
- Act as the ALRP (Affiliate Labeling Responsible Person) for Korea to comply with label process, when applied
- Responsible for reporting all AEs cases received in territory to the Global PV team as Elanco's SOP and overseeing the AEs related things to meet global/local regulatory requirements as Affiliate Responsible Person(ARP) for Pharmacovigilance
- Perform any other tasks as assigned by supervisor
- Coordinate the execution of local development and post-marketing studies when applied.
- Ensure all activities comply with legal & ethical standards as well as company policies. Minimum Qualification (education, experience and/or training, required certifications):
- At least Bachelor degree of veterinary medicine, pharmacist or equivalent in science-based field
- The minimum experience in the Veterinary Medicine Industry of at least 3 years, and RA and equivalent experience should be at least 10 years.
- Able to work independently under pressure and compliance with strict deadlines
- Experience successfully completing new product approval in Veterinary medicines & understanding of the regulated environment
- Establishing relationship with Regulatory agencies and other institutes colleagues
- Excellent computer skills and proficient in MS Word, MS Excel, Power point and Outlook
- Language : Fluent in English both written and spoken Additional Preferences:
- Knowledge to understand commercial background is preferred.
- Accountable for Results, Good multiple-tasking focus, Strong follow through and closure of matter/case
- Persistence and Stability, Results Orientation, High learning agility, Proactive and fast response, Having a sense of urgency, Problem Solving Ability, Attention to details and adherence to guidelines
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Regulatory Affair Manager - South Korea, 대한민국. - Elanco
5일 전
설명
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:
