Bridgewater Township, NJ - Regulatory Affairs

Regulatory Affairs opportunities are now available in Bridgewater Township, NJ through Adecco Medical and Science.

This is a contract opportunity, with a possibility of an extension.

Position Responsibilities:
Support the Active Ingredient Solutions (SAIS) Regulatory/Quality Zone Head in the following:

Responding to US RA customer requests.
Log and track in customer database.
Hold sales and RA weekly meeting to track progress of customer requests.
Review and publishing of Administrative and Technical amendments to the FDA for SAIS Drug Master Files.
Work closely with the site to ensure document are accurate for submissions.
Respond to FDA Deficiency Letters.
Hold meeting(s) with site to discuss content of letter if needed.
Hold meeting(s) with customers affected by the deficiency letter.
Coordinate with the site timelines to respond to FDA deficiency letter.
Request publishing, review the response to ensure it is publishing ready, and publish document to FDA.
Send and track Information Letters to each Customer.
Regulatory Intelligence.
Alert and inform sales managers and BU manager of US governmental policies, FDA guidance and trends that may affect our US business.


Required Skills:

MS Office 2010,
Technical working knowledge and hands-on experience with fermentation processes.
Basic technical writing and documentation skills.
Equipment and process troubleshooting skills.
Excellent verbal and written communication skills.
Ability to work in a team environment.
Self-motivated and willing to be proactive in resolving issues.
Years of Experience: 0 - 3 Years.
Must have a B.S in biology, chemistry, etc. looking for a recent college grad with a science degree.


Education Requirement:

Bachelor of Science in Biology.


Shift Start/End Time: Monday through Friday – Days
Dress Code: To be determined.
Contract Length: June 23, 2020 to December 31, 2020, with the possibility of an extension.

If you are interested in this position, please click APPLY NOW. If you have questions or would like additional information, please apply and we can discuss any questions you may have at that time. While applying, please upload a .DOC or .DOCX formatted resume for our review.

Equal Opportunity Employer/Veterans/Disabled. To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit http://www.adeccousa.com/candidate-privacy/. The Company will consider qualified applicants with arrest and conviction records.

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Reference number US_EN_2_101084_335607