Coordinator, Regulatory Submissions

6 days ago

Singapore Labcorp Full time

**Responsibility**:

- Under the direction of senior staff, assist with the formatting and compilation of regulatory submissions through such tasks as entering information into Tables of Contents and creating tabs and submission labels.
- Provide support assistance to senior staff in the upkeep of regulatory authority submission and correspondence logs (add entries to Tables of Contents, file submission letters and other correspondence).
- Generate routine submission cover letters to regulatory authorities and clients.
- Track, inventory and organize individual components of regulatory submissions.
- Perform document acceptability checks of submission components.
- Liaise with the Publishing group in the generation of submissions.
- Provide support assistance to senior staff in the oversight, final preparation and generation of submission documents.
- Perform a quality check of final submission documents.
- Update status reports and tracking sheets of ongoing and pending regulatory projects with input provided by senior staff.
- Organise shipping of documentation to clients, regulatory authorities and within Labcorp.
- Perform other job functions, such as word processing, as needed to accomplish the above listed duties.
- Perform other activities as required by management.

**Education/Qualifications**:

- Bachelor’s Degree in Life Sciences or equivalent

**Experience**:
**Minimum Required**:

- Excellent verbal and written communication skills.
- Computer literacy in basic functions (Word, Excel)
- Good planning and organizational skills; detail oriented.
- Flexibility, ability to switch back and forth between multiple projects/tasks.

**Preferred**:

- Understanding/knowledge of drug regulations
- Understanding of the drug development process

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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