-
Guerbet Seoul, 대한민국. Long-term/regularMedical Affairs Manager M/F · At Guerbet, we build lasting relationships so that to enable people to live better . This is Our Purpose. · We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, ...
-
Baxter Seoul, 대한민국. 풀타임This is where you save and sustain lives · At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves out ...
-
Gilead Sciences, Inc. Seoul, 대한민국. 풀타임**For Current Gilead Employees and Contractors:** · Please log onto your Internal Career Site to apply for this job. · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – wo ...
-
Gilead Sciences Korea Limited Seoul, 대한민국. 풀타임Description · Gilead is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of high unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world ...
-
Novo Nordisk A/S Seoul, 대한민국.Are you passionate about ensuring patient access to life-changing therapies? Do you have experience in market access strategy and negotiations? We are looking for an External Affairs Lead (Obesity dedicated) at Novo Nordisk. If you are ready to make a difference and contribute to ...
-
Novo Nordisk Seoul, 대한민국.The position · This role involves leading public affairs projects to enhance awareness among public policy stakeholders and other internal and external stakeholders about Novo Nordisk's value to patients and their families. It also includes maintaining and strengthening relation ...
-
Novo Nordisk Seoul, 대한민국.Are you passionate about ensuring patient access to life-changing therapies? Do you have experience in market access strategy and negotiations? We are looking for an External Affairs Lead (Obesity dedicated) at Novo Nordisk. If you are ready to make a difference and contribute to ...
-
Pfizer Seoul, 대한민국. 풀타임Job Responsibility · Assists in filing and obtaining marketing approval from the MFDS for a planned new drug (K-NDA) and ensures subsequent maintenance of drugs registered (Supplemental & Amended K-NDA). · Ensures quality filings of K-IND submission and its approval. · Updates ...
-
622 GlaxoSmithKline Korea Limited Seoul, 대한민국. 풀타임Please note it is your responsibility to notify your manager if you are interested in applying to an open position prior to the interview taking place. Please refer to your local policy for more information and guidelines. · Organizational context: · 1. Reporting to Oncology Med ...
-
The Medical Affairs Company Seoul, 대한민국.Join the TMAC MSL and CTL Network in South Korea · TMAC - Seoul, South Korea · Partner with the industry's leading provider of comprehensive medical affairs and clinical teams. · Whether you are actively seeking a position or just keeping an ear to the ground for opportuniti ...
-
Santen Inc Seoul, 대한민국. 풀타임[KOREA] Medical Science Liaison · Full-time · Company Description · Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated ...
-
Pfizer Seoul, 대한민국. 풀타임PURPOSE · Sr. Medical Affairs Scientist (MAS) main role is to create and implement strategies, to build and develop enduring peer-to-peer relationships with healthcare professionals and institutions, creating constructive, cross-functional partnerships with internal and externa ...
-
Electronic Arts Seoul, 대한민국. RegularRequisition Number:183871Can this position be remote?: No We are a global team of creators, storytellers, technologists, experience originators, innovators and so much more. We believe amazing games and experiences start with teams as diverse as the players and communities we ser ...
-
P&R Specialist
1주 전
AstraZeneca Seoul, 대한민국. 풀타임Role description · Develops and implements pricing and reimbursement strategies for new products reimbursement/ reimbursement scope expansion to secure accelerated market access with optimal pricing · To minimize price erosion or access restriction due to various cost containme ...
-
Pfizer Seoul, 대한민국. 풀타임ROLE SUMMARY · The Platform: The Chief Medical Affairs Office's RWE Partnerships and Platforms organization is responsible for establishing global RWE data and scientific leadership through the generation of integrated, end-to-end observational real-world evidence serving all th ...
-
RA specialist
2주 전
Takeda Seoul, 대한민국. 풀타임Description · Job Title: RA specialist · Location: South Korea, Seoul · About the role: · Comprehend priorities and objectives of Takeda and commit to working towards it · Develop working relationships with GRA, GEMRA and the local regulatory authority to ensure optimal stakeh ...
-
RA Specialist
3일 전
Ortho Clinical Diagnostics Seoul, 대한민국. 풀타임The Opportunity · QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are m ...
-
Sr. RA Specialist
1주 전
Zimmer Biomet Seoul, 대한민국. ExternalJOB DESCRIPTION At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. · As a Zim ...
-
QA Specialist
5일 전
Zimmer Biomet Seoul, 대한민국. 풀타임At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. · As a Zimmer Biomet team m ...
-
Lead RA Specialist
2주 전
GE Healthcare Seoul, 대한민국. 풀타임**Job Description Summary** · We are the doers. The leaders. The makers. The change-bringers. We are all different, uniting to solve the world's toughest challenges. Our teams are hungry to make history, acting with integrity to relentlessly improve people's lives. With every wel ...
Regulatory Affair Manager - Seoul, 대한민국. - Elanco
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 PurposeTM – 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 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
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
R0018707
