Senior Specialist, Global Regulatory Operations

Summit, NJ, US
Nov 21, 2018
Required Education
Bachelors Degree
Position Type
Full time
Req #: 1803293
Location: Summit, New Jersey, United States
Job Category: Regulatory Affairs
Work Location: 86 Morris Avenue 07901
Organization: Regulatory Affairs
Employee Status: Full-time
Job Type: Regular

POSITION: Senior Specialist, Global Regulatory Operations

• Bachelor's Degree (or equivalent experience) with at least 4 years of eCTD publishing experience. Pharmaceutical industry experience preferred.
• Knowledge of IND, NDA, MAA, CTD requirements and guidelines; both paper and electronic required.
• Must have technical knowledge of electronic publishing systems and software.
• Knowledge of health authority procedures/guidance's regarding electronic submissions required.
• Must have knowledge of Electronic Document Management Systems.

Responsibilities will include, but are not limited to, the following:
• Support Regulatory Affairs personnel in the coordination, preparation, and submission of all INDS/NDAs/MAAs and life cycle management of these submissions in both paper
and electronic format. Responsible for the creation and compilation of quality Regulatory submissions and lifecycle management submissions. Planning, preparing, tracking, and archiving regulatory documents and submissions.
• Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including MAAs/NDAs, INDs, 51O(k)s, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, etc.
• Support several INDs as the Regulatory Operations Lead. Responsible for setting submission timelines and final XML reviews. Provide guidance and support to electronic submissions specialists.
• Responsible for setting up kickoff meetings and setting timelines for Orphan Drug
Annual Reports.
• Responsible for maintenance of all Regulatory and FDA correspondence (distributing, and archiving into electronic document management system) within specified time frames.
• Verification of regulated documents via workflows within Celgene's electronic document management system (eSub livelink).
• Adherence to required submission timelines, health authority publishing specifications, and internal working practices.
• Liaise with functional source areas (clinical, nonclinical, erne, 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.
• Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
• Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
• Other responsibilities related to the above within Celgene as a whole, as assigned.

Minimum Skills/Knowledge Required: .
• BA/BS degree or equivalent, at least 4 years pharmaceutical industry experience, and prior
Regulatory Operations experience required.
• Knowledge ofiND, NDA, MAA, CTD requirements and guidelines, both paper and electronic.
• Knowledge of industry trends regarding electronic submissions.
• Technical knowledge of electronic publishing systems and software.
• Proficiency with MS-Office Suite and Adobe Acrobat application .
• Knowledge of health authority procedures/guidance's regarding electronic submissions.
• Knowledge of Electronic Document Management Systems.
• 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.

About Us


At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.