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Associate Director of Regulatory Affairs

Eden Prairie, MN

Piper Companies Logo

Job Id:
143117

Job Category:
Life Sciences

Job Location:
Eden Prairie, MN

Security Clearance:
No Clearance

Business Unit:
Piper Companies

Division:
Piper Clinical Solutions

Position Owner:
Dylan Fuchs

Piper Companies is currently looking for an experienced Associate Director of Regulatory Affairs in Eden Prairie, Minnesota (MN) to work for an innovative and growing pharmaceutical manufacturer. (Relocation Assistance Available)


Responsibilities for the Associate Director of Regulatory Affairs include:

·      Contribute to and execute the overall regulatory strategy for new and existing products, ensuring compliance with global regulations.

·      Act as main contributor in the drafting of IND Submission documentation pertaining to new biologic pharmaceutical products

·      Oversee project management of the IND submission life cycle

·      Provide training to team members on regulatory requirements and procedures


Qualifications for the Associate Director of Regulatory Affairs include:

·      12+ years of experience within pharmaceutical regulatory affairs

·      Hands on experience with IND Submission writing

·      5+ years of experience with biologic pharmaceutical products

·      B.S. in Regulatory Affairs or related field required


Compensation for the Associate Director of Regulatory Affairs include:

·      Salary Range is $165,000-$225,000 dependent upon experience

·      Comprehensive benefits package


Keywords 

Associate Director Regulatory Affairs, pharmaceutical, IND Submission, FDA Submission, manufacturing, research, GMP, GXP, science, comprehensive benefits package, #LI-ONSITE #LI-DF1

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