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존슨앤드존슨 [한국얀센] Associate RA Manager About Johnson & Johnson At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal. Through our expertise in pharmaceutical, medical devices and diagnostics markets, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
[Summary] Manages submission of new product applications to the regulatory agencies. Directs and coordinates activities concerned with the submission and approval products to government regulatory agencies. Provides guidance to project team members regarding regulatory compliance issues. Oversees the preparation and maintenance of regulatory submissions and files. Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products and other products. Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters. Consults with management personal to establish strategies and prepare appropriate regulatory filings for the regulatory activities. In general, has responsibility for projects of medium and large scope, such as accountability for regional/global/multi-functional projects.
[Responsibilities] Functional and Technical Competencies: - Leverages deep knowledge of the regulatory environment, including compliance, current and proposed laws, regulations and guidance, to develop and oversee the execution of compliant Regulatory strategies that are aligned with business objectives of the company. - Leverages a deep scientific and technical understanding of products (medical devices, biologics or pharmaceuticals). - Encourages and leads others to find ways to continuously improve, learn about new scientific, technological and Regulatory developments, develop new capabilities, and learn from past challenges and experience in order to proactively adapt to change and drive innovative thinking. Manages projects within timeline and budget requirements by acquiring and coordinating needed resources. - Leverages in-depth knowledge of the sector, organizational vision, Regulatory Affairs function, and cross-functional business partners to make informed business decisions and create and execute business strategies. - Leverages knowledge of the healthcare environment and external marketplace Leadership Competencies: - Guides others in defining and prioritizing key decision criteria, considering the benefits and risks of alternatives, Credo, and evaluating immediate and future implications when making business level decisions. - Quickly and effectively prioritizes critical Regulatory Affairs goals/ initiatives and manages resources in difficult, complex, or crisis situations. - Manages change by creating structure and providing clear direction when facing ambiguity and uncertainty. - Understands others’ motivations, needs, and concerns even when they are difficult to discern and applies understanding to establish trust and credibility and influence others. - Creates compelling negotiating positions that build support and consensus among key stakeholders. Challenges the positions of others to reach win-win outcomes. - Mentors others in using verbal communication that are convincing, engaging, and articulate and translate complex information into key facts and rational arguments that are influential, meaningful, and actionable. - Fully engages others by asking incisive and provoking questions, always ensuring mutual understanding, particularly when encountering conflicting opinions.
[Requirements] - 8+ years Regulatory Affairs or related field, Medical Device experience - Experienced in dealing product registration, registration maintenance and KGMP in medical device product categories - Experienced in developing team and leading team project - Excellent communication and strong interpersonal skills - Ability to collaborate with cross-functional partners/teams - Strong project management skills - Well defined problem solving - Strong sensitivity for dynamic and multi-cultural environments - Experienced in driving industry projects as a lead - Experience with international regulations - Proven analytical abilities - Fluent in both verbal and written English and Korean
[지원
방법]
국&영문 자유 양식의 이력서/자기소개서 [서류
마감일] [For more Johnson & Johnson] - J&J Careers 유튜브 채널 : https://www.youtube.com/channel/UCZEsWOZwbcjcXHrgYq7sP4Q - J&J Korea Facebook: https://www.facebook.com/JNJCareersKorea/ - J&J Linkedin: https://www.linkedin.com/company/johnson-&-johnson/ - J&J Corporate Page: http://www.jobkorea.co.kr/Company/1605233/Info
[유의사항] - 국가 보훈 대상자 및 장애인은 관련 서류 제출 시 관계 법령에 의거하여 우대합니다. - 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연될 수 있습니다. - 입사 지원 서류에 허위 사실이 발견될 경우, 채용 확정 이후라도 채용이 취소될 수 있으며 향후 채용이 제한됩니다. - 제출된 서류는 반환되지 않으며, 별도 요청 시 삭제합니다.
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