Regulatory Associate job in Rockville, USA

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First Name*

Last Name*

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Job type: Permanent

Discipline: Officer /Associate, Publishing & Submissions, RA Intelligence

Location: United States

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

Proclinical is currently recruiting for a Regulatory Associate with a pharmaceutical company located in Rockville, MD.

Job Responsibilities:

Assist Biopharm site regulatory submission preparation & review of global submissions, variations/supplements for products produced by the Biopharm site. This includes both IND and approved commercial products.
Support Response to Questions (RTQ's). Support Market Specific Requirements (MSR's). Support renewals.
Support change notifications from Vendors by assessing regulatory impact.
Support changes to site specifications
Initiate change controls for new market submissions.
Support Annual Reports for commercial products. Support Periodic Product Review reports for commercial products.

Skills and Requirements:

Minimum BS/BA in Technical or Analytical discipline
Minimum 1-5 years industry experience in biopharmaceutical/biologics manufacturing environment.
0-3 years prior experience in regulatory functions.
Good understanding and interpretation of Global regulations pertaining to the manufacture, holding, and distribution of biopharmaceuticals/biologics.

If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at 267-297-3257.

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

Proclinical Staffing is an equal opportunity employer.

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