Senior Specialist, Global Regulatory Operations

Summit, NJ, US
Nov 21, 2018
Required Education
Bachelors Degree
Position Type
Full time
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.

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.

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.