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Specialist (Global Regulatory Operations)

Req #: 1700563
Location: Summit, NJ US
Job Category: Regulatory Affairs
Work Location: 86 Morris Avenue CELSUM 07901
Organization: Celgene Corporation
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- NJ- Summit East

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Responsibilities will include, but are not limited to, the following:

1. Support Global Regulatory Operations Leads in the coordination, preparation, and submission of all INDS/NDAs/MAAs & 510Ks and life cycle management in eCTD as well as paper and NeeS formats.

2. Responsible for the creation, assembly, publishing, and verification of both major and routine regulatory dossier submissions, including IND safety reports, DSUR, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Responses, etc.

3. Responsible for maintenance of all Regulatory and Health Authority submission archiving within specified time frames.

4. Verification of regulated electronic documents via workflows within Celgene’s electronic document management system.

5. Adherence to required submission timelines, health authority publishing specifications, and internal working practices.

6. Liaise with functional source areas (clinical, nonclinical, cmc, regulatory) to ensure documents are compliant with authoring style guide.
- Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.
- Close interaction with authoring community to track availability of deliverables.

7. Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.

8. Other responsibilities related to the above within Celgene as a whole, as assigned.


Qualifications

Skills/Knowledge Required:

•2 yrs. pharmaceutical industry experience required (MUST specifically be in Regulatory Operations)
•BA/BS Degree or equivalent experience
•Demonstrated experience with compiling eCTD submissions in a publishing tool (eg, eCTDXPress, eCTDManager, ViewPoint, etc)
•Technical knowledge of electronic publishing systems/document management systems and software
•Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic
•Proficiency with MS-Office Suite and Adobe Acrobat applications
•Knowledge of health authority procedures/guidance’s regarding electronic submissions
•Ability to balance multiple tasks to meet priorities and timelines
•Self-starter with superior time management skills, and ability to work independently or in teams
•Strong attention to detail

*No remote or tele-commute - all work must be on site

Job Posting Number of Positions

1

Business Unit

1010 - Celgene Corporation

Physical Location of Worker

Celgene Summit

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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