서울 지역 regulatory affairs specialist 관련 취업정보
정렬방식: 연관성 - 등록일
채용공고 14개
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Job Post Details
Specialist, Regulatory Affairs - job post
3.6별점 3.6/5점
서울
정규직
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Job Summary
With a passion for science and creativity, we seek to deliver the answers our customers need so they can produce life-saving drugs, everyday wellness solutions and vital consumer products. Deep polymer and applications expertise mean we dig deeper to ensure performance and process benefits for customer formulations. And with our commitment to quality, reliability, and sustainability, we can deliver solutions that help benefit our world.
To know more about Pharma Solutions, pls visit https://pharma.iff.com/ or https://www.linkedin.com/showcase/iff-pharma-solutions/.
The Regulatory Specialist is responsible for providing hands-on regulatory support for the development and maintenance of our Pharmaceutical Solutions business.
Specific Responsibilities include:
- Support existing product portfolio in their pharmaceutical applications for new market/applications and introduction of existing products.
- Hand on involvement in dossier work for regulatory submission, including collaborating with different stakeholders in various countries to create document for dossier, compliation of dossier and submission to regulatory bodies.
- Keep dossier and regulatory submission updated as and when required.
- Ensure compliance of pharmaceutical ingredients, food additive in the application of medicinal drug, nutraceutical, personal care and industrial application.
- Monitor regulatory changes, assess impact of regulatory changes to business and communicating impact to business and relevant stakeholders in a timely manner.
- Provide input to new projects, new product developments and supporting dossier work on an as needed basis.
- Support customer regulatory filing by obtaining/creating necessary document, as needed, in alignment with IFF policies
- Support of regional/global internal stakeholder (e.g. commercial teams, quality, operations, R&D) as and when needed on regulatory information/issues.
- Involvement with local competent authorities and trade associations, as needed.
PREFERRED EXPERIENCE & QUALIFICATIONS:
- Understand the regulatory landscape/submission requirement for pharmaceutical excipients and their use in finished drug products, food additives, nutraceutical and personal care in Korea.
- Has interacted with regulatory agencies and has track record in product clearance/registrations and regulatory negotiations.
- Knowledge in Korea pharmaceutical regulations, excipients will be an advantage
- MSc or BSc degree in Pharmaceutical Science, Regulatory Science, Biology, Toxicology, or Chemistry or similar fields
- Min. 2 to 5 years Regulatory Affairs work experience
- Demonstrate analytical, conceptual and strategic thinking as well as excellent communication skills across a global team.
- Strong interpersonal skills
- Very good organization, and project management competencies
- Strong influencer and collaborator with interdisciplinary teams
- Agile
- Food Regulatory Knowledge will be an advantage
- Language: English (advance level) for writing, reading and speaking.
- Korean (advanced level) for writing, reading and speaking.
- Willing to learn and develop new skills to support new business in Korea as well as in ASEAN & OCEANIA.
We are a global leader in taste, scent, and nutrition, offering our customers a broader range of natural solutions and accelerating our growth strategy. At IFF, we believe that your uniqueness unleashes our potential. We value the diverse mosaic of the ethnicity, national origin, race, age, sex, or veteran status. We strive for an inclusive workplace that allows each of our colleagues to bring their authentic self to work regardless of their religion, gender identity & expression, sexual orientation, or disability.
Visit
IFF.com/careers/workplace-diversity-and-inclusion
to learn more
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