Regulatory Affairs Manager

Sterling-Hoffman Executive Search Located in: Kansas
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JOB DESCRIPTION

Our client, a leading veterinary pharmaceutical company, is currently seeking an accomplished Regulatory Affairs Manager to join the team. Here is an overview of the role:

1) Publish and manage regulatory submission documents such as INDs, NDAs and IMPDs
2) Manage electronic submission activities to meet the company's targeted submission timeline
3) Communicate with the e-submission vendor as necessary for an efficient and accurate electronic submission workflow
4) Train the internal document authors along with the common technical document template
5) Check the submission documents for their accuracy
6) Monitor and track regulatory trends and newly published regulatory guidelines
7) Review technical reports, summary documents and change controls for appropriate content and justifications as well as for adherence to regulatory guidelines, strategies and commitments
8) Provide project management related activities required for FDA submissions for internal and external projects
9) Educate partners regarding U.S. regulatory requirements including cGMPs, CMC requirements and generic drug user fee amendments requirements
10) Perform launching of new drug products which includes filing PLAIRs, performing product inspections, assisting with completion of vendor files and compiling of required launch documents and drug listings

CRITICAL REQUIREMENTS

  • 1) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    2) Recent experience in the veterinary pharmaceutical industry is strongly preferred
    3) Preference will be given to candidates with recent experience in regulatory affairs management

    This role is a great opportunity for the right person looking to advance their career with a wonderful company. If you are qualified and think that you are a strong fit for this role, please apply ASAP!

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION

Seniority Level:
Management / Supervisory
Function:
  Regulatory Affairs
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: