Associate Director of Regulatory Affairs

Overview

On Site
USD 165,000.00 - 225,000.00 per year
Full Time

Skills

Regulatory Compliance
Technical Drafting
Documentation
Management
Project Management
Training
Writing
Pharmaceutics
Regulatory Affairs

Job Details

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

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