Our Recruitment Policy
- We go with talents having ‘growth potential’.
- We offer challenges and opportunities for ‘growth’.
- We offer a good environment so that employees can autonomously ‘focus’ on work.
- Daewoong have R&D (Formulation & Analytical), Quality Assurance, Regulatory affairs, C&D, HR & Admin, Finance depts.
- If you’re ready to grow your career, here is the opportunity. Send your resume to dwihr@daewoong.co.kr
Direction that Daewoong should take and the culture in which Daewoong employees work.
Growth
Our goal is to help you 'grow' as the industry's top human resource.
Autonomy
We provide an environment where you can 'autonomously' immerse yourself in work.
Performance
We focus on working properly to exhibit 'performance'.
Available Positions
Job Description
- Prepare and submit regulatory dossiers for product registrations, import licenses, and amendments to the CDSCO.
- Maintain up-to-date knowledge of Indian medical device regulations (Medical Device Rules, 2017 and amendments).
- Liaise with CDSCO, state licensing authorities, and third-party regulatory consultants.
- Support Quality Assurance in audits, product recalls, and field safety corrective actions.
- Ensure compliance with India-specific labeling, documentation, and advertising regulations.
- Monitor and assess changes in regulatory guidelines and communicate impact to cross-functional teams.
- Maintain regulatory files and tracking systems for timely renewals and updates.
- Collaborate with global regulatory teams to ensure consistent strategies and compliance.
Requirement:
- Master’s degree in Pharmacy or a related field
- 5 – 8 years of hands-on experience in regulatory affairs for medical devices and experience with Class C & D devices preferred
- Strong knowledge of CDSCO regulations and submission pathways
- Excellent communication and project management skills
- Familiarity with ISO 13485, EU MDR, and US FDA regulations is a plus
1) Develop and validate analytical methods for finished products for regulated markets (US and Europe market)
2) Handling equipment like HPLC, UPLC, GC dissolution tester, UV/ Vis spectrophotometer, IR, KF titrator etc
3) Trouble shoot in existing methods and support regular and stability analysis, Excipient analysis for formulation development
4) Preparing reports like method development report, validation protocols and reports, specifications, stability protocols etc
5) Minimum 3 – 5 years experience in Formulation AR&D with Master’s degree. (Preferably experience in OSD).