Regulatory Affairs Manager

Sterling-Hoffman Executive Search Located in: Tennessee
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JOB DESCRIPTION

A leading company in the pharmaceutical industry is currently seeking a Regulatory Affairs Manager to join their team. For the right executive, this is a fantastic opportunity with great growth prospects. Key duties include:

1) Review technical reports and summary documents
2) Follow regulatory guidelines, strategies and commitments
3) Liaise with contract manufacturing partners
4) Review stability protocols, specifications, batch records, technical reports and change controls and recommend changes, as appropriate
5) Ensure compliance and conformance with existing regulatory applications and approval
6) Review batch documents from CMOs and perform batch release
7) Perform QA audits of 3rd party vendors
8) Serve as a Regulatory Representative on internal and external product teams
9) Provide regulatory subject matter advice to the QA Department, as needed
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

    If you are qualified and aspire to work for an excellent, established company whose employees believe in teamwork and make great contributions to the industry, then this could be a golden opportunity for 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:
Management / Supervisory
Function:
  Regulatory Affairs
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: