Regulatory Operations Lead job in Piscataway, New Jersey

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Operations

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical, in support of a growing biotech, are seeking a strong leader to help expand the regulatory operations capabilities of our client. Reporting to the Head of Regulatory Affairs, the successful candidate will have a key role in helping to shape the Regulatory Operations group.

Responsibilities

Manage Veeva implementation.
Publish of all submission source documentation as well as submission dossier compilation and dispatches to multiple Health Authorities.
Accountable for all Publishing activities, verification, dispatch and management of major and routine submissions in e-CTD format.

Plan, prepare, track and archive regulatory documents and submissions.
Set up kickoff meetings and setting timelines for major submissions
Adhere to required submission timelines, health authority publishing specifications, and internal working practices.
Partner with subject matter experts relevant departments to develop and implement processes supporting document authoring, submission compilation archival, and planning and tracking of regulatory submissions and health authority interactions.
Assist with QC checks of authored documents for against source data during review.

Skills and Qualifications

BA/BS or equivalent, and 8+ years of eCTD publishing experience in pharmaceutical industry.
Knowledge of health authority procedures/guidance regarding electronic submissions.
Knowledge of industry trends regarding electronic submissions.
Knowledge of IND, NDA, MAA, CTD requirements and guidelines.
Technical knowledge of electronic publishing systems and software. Experience with Veeva preferred.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Tudor Carr at (+1) 617-545-5919 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-TC1

Salary

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