Regulatory Operation Specialist

[Role description]

Regulatory Operations Specialist is responsible for taking the most appropriate actions to ensure excellence in operating Regulatory (including GRP) and digital tools supporting activities.

[Typical Accountabilities]

Regulatory operations and GRP compliance

- Ensure labelling quality from the preparation of the local proposal of regulatory text to the label on packages by Quality, editorial review of the draft Korean label text before its submission to MFDS and of the artwork compliance as per the local regulations and company standard.

Operation of Electronic labelling (E-labelling) and its maintenance is also one of key activities ensuring high labelling quality.

Monitor the compliance to Regulatory procedures including timely, accurate recording on RIMS as per Global procedures and important performance indicators such as adherence to agreed submission timeline, timely tracking of the MFDS outcomes, execution of regular updates and renewals for licenses to operate.

- Report operational company updates to MFDS.

The reports include but not limit to product supply discontinuation or shortage and annual reports of site registrations or drug master files. To prepare the report to MFDS all the internal communication shall be accurately completed in advance.

- Arrange documentation of Quality events on the Global system. Typically GRP change controls, Quality Incidences, Effectiveness Checks, Impact Assessment and action items are in scope of the documents those to be owned or initiated.

As per the internal procedures the documentation should be distributed to appropriate experts for their contribution and consolidated for the comprehensive understanding and for making right decision.

- Support regulatory filings for NDAs, new indications and lifecycle management with submission excellence using digital tools which are ongoing or upcoming from local environment or from company initiatives. To be trained with new procedures and/or systems and introduce appropriately for Local implementation as applicable.

Where needed, act as the primary operator of existing or new systems and arrange available training for staff

Where applicable, design and propose the efficient way of working for the team, keeping ensured the compliance to Global standard and local expectation.

- Ensure security on MFDS NEDrug system. NEDrug account and delegated privilege of intended submission, filing or reporting shall be controlled on the standard expectation of electronic security standard.

- Manage non-filing documents. Procedural documents shall be maintained on the Global system as per the company procedures. Other non-filing records with paper-type and electronic-type shall be archived as per the relevant Global standard.

Contract/agreement execution and management

- Payment/expense management

- Regular monitoring and reporting of contract execution with government or agencies

- Service provider management

[Skills]

- Good command of spoken and written English

- Good command of digital/IT tools

- Problem solving skills

- Focus on delivery and results

[Qualifications]

- Education: BA or MA biology-related science (pharmacy preferred)

- Language: Korean and English

- Work Experience: Regulatory or pharma industry experience preferred

- Competencies: Understanding of GxP principles, strong commercial awareness, collaborative working relationships, regulatory knowledge, experiences of working on Quality management procedures

[ 채용 절차법에 따른 고지 사항 ]

1. 전자우편으로 제출한 서류는 채용 절차법에 따라, 일체 반환 의무가 없습니다.

2. 보훈대상자 및 취업보호대상자는 관련법에 의거하여 우대합니다.

3. 지원자는 입사 시 해외 여행 결격사유가 없어야 한다는 점 안내 드립니다.

4. 본 채용은 수시진행으로, 적격 후보자 채용 시 마감될 수 있습니다.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.