Remote: Drug Product Export SME (229555)

Life Sciences & Technology
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Job Description:

A Black Diamond client is looking for an Export SME to help them ship API from EU to UK, and then Drug Product from the UK to the US. The first batch of product due to ship in the next couple of weeks is raw material for R&D batch. Animal derived product from a GMP certified facility. They are looking for someone with extensive experience with the regulatory paperwork and contracts to export out of the EU and UK. Eventually they will need help shipping the finished drug product from the UK to US.

 

Required Skills:

  • Familiarity with FD&C Act Section 502 and 801
  • ICH Q7A
  • 21 CFR 201.122 and 312. 160
  • 505 (b)(2) Regulatory pathway
  • Certificate of Medicinal Product (CMP), MAA, Article 58 Regulation (EC) No 726/2004

 

 

Remote: Drug Product Export SME (229555)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Remote

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