[한국얀센] Regulatory Affairs Specialist

[한국얀센] Regulatory Affairs Specialist

[접수기간]

22년 12월 29일 ~ 채용 시 마감 

[전형절차]

서류 > 면접

[Summary]

- New product registration

- CMC variations of approved products

- Label updates (including CCDS update)

- Clinical trial application to MFDS

- Support of regulatory activity in license management

[Responsibilities]

1. New product registration

- Communicating with regional RA to get the dossier in a timely manner

- Reviewing the dossier and submitting to MFDS with product information reflecting opinions from other departments

- Timely submission of supplemental documents requested by MFDS, if any

2. CMC variations of approved products

- Reviewing the dossier and submitting to MFDS in line with Q&C

- Timely submission of supplemental documents requested by MFDS, if any

3. Label updates

- Reviewing the documents forwarded from regional RA and submitting to MFDS

- Timely notification of label changes in accordance with appropriate SOP

4. Clinical trial application to MFDS

- Communicating with GCO and regional RA to get the dossier in a timely manner

- Reviewing the dossier and submitting to MFDS

- Timely submission of supplemental documents requested by MFDS, if any

- Management of promotional materials with out of date product information

5. Support the regulatory activities in license management, if any.

- Assist in SOP development and review.

- Provide regulatory input to product lifecycle planning.

*Key Working Relationships

1. Internal

- All departments of Janssen Korea, especially production, Q&C, logistics, marketing, PR, GCO, Market Access, Medical, etc.

- Regional RA

2. External

- Ministry of Food and Drug Safety

- Healthcare professionals

[Requirements]

1. Education: a Bachelor or higher degree in pharmacy, or equivalent training as a healthcare provider

2. Experiences: previous experience on the pharmaceutical industry or medical environment is desired

3. Essential knowledge & skills

- Sound knowledge of general medicine or pharmacy and clinical practice

- Knowledge of local regulatory requirements/guidelines and global standards

- Fluency in written and spoken English in addition to local language(s)

- Awareness and familiarity with industry principles of drug development and pharmacology

- Proficiency in Global and Local SOPs

- Knowledge of the Janssen Korea products

- Good interpersonal communication skills

- Ability to negotiate and communicate with internal and external customers

[채용공고]