Regulatory Manager

Sterling-Hoffman Executive Search Located in: Kansas
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JOB DESCRIPTION

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

1) Provide regulatory guidance and strategy to global developments and marketed product teams on CMC aspects of projects
2) Lead cross-functional teams to support CMC submission activities and ensure compliance with regulatory requirements
3) Maintain thorough knowledge of laws, regulations and guidelines covering pre and post approval CMC regulatory requirements and application maintenance
4) Interface with the FDA and other regulatory agencies, including scientific reviewers, administrative staff and management
5) Coordinate, author and review CMC section of submissions for biological products to international regulatory agencies
6) Provide regulatory analysis and time estimates for CMC submissions to regulatory agencies
7) Assist in planning and conducting meetings with regulatory agencies
8) Provide evaluation and risk assessment of, and answer to, regulatory CMC inquiries from regulatory agencies
9) Perform change management to establish the regulatory impact of changes and ensure compliance of registered commitments
10) Perform other duties as assigned

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 pharmaceutical industry is strongly preferred
    4) 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: