Regulatory Affairs Director - CMC

Sterling-Hoffman Executive Search Located in: Kansas
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JOB DESCRIPTION

Our client, a leading veterinary pharmaceutical company, is currently seeking an ambitious and gifted Regulatory Affairs Director - CMC to take their team to new heights of success. This is a unique opportunity for a highly motivated executive with a go-getter attitude and a drive to succeed. Key duties include:

1) Manage products and change controls in compliance with regulations and company policies and procedures
2) Prepare, review, analyze, and approve change requests
3) Keep management informed of potential issues
4) Provide strategic advice into CMC, non-clinical & clinical issues
5) Write and review CMC documents
6) Provide strategic and operational leadership support on CMC challenges
7) Write and review section manufacturing, development plans and analytical development documents
8) Assist with business development activities
9) Contribute to the development and implementation of procedures and policies for regulation of marketed promotional materials
10) Develop strategies for regulatory approval and introduction of new products to market

CRITICAL REQUIREMENTS

  • 1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
    2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    3) Recent experience in the veterinary pharmaceutical industry is strongly preferred
    4) Preference will be given to candidates with recent experience in global CMC strategy and documentation development

    For the right leader, this role is a fantastic opportunity to be a key player in the exceptional success of this renowned company. If you are qualified and think this could be you, 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:
Director / VP
Function:
  Regulatory Affairs,  Compliance
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: