Regulatory Affairs Compliance Specialist

Sterling-Hoffman Executive Search Located in: Newport,  Vermont
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Sterling-Hoffman Executive Search Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

Partial Job Description 1) Manage the various projects involved with QA/QC and regulatory compliance 2) Ensure labeling systems administrator which includes master file management and label proofing 3) Manage project as assigned and prioritized by Director QA/QC and Regulatory Compliance 4) Manage state and federal applications, licenses and regulatory documents 5) Ensure labeling which includes reviewing and authorizing all labeling for compliance content 6) Ensure all FDA, FTC and USDA correspondence, including Structure Function Claims, NDIs and NOP certification 7) Create new regulatory sheets for new products and request documents for new product launches 8) Manage version control 9) Create new product substantiation binders 10) Manage change control file and database 11) Ensure GMPs system, process validations and FDA protocol 12) Prepare SOPs for distribution and finalize RDLs for use 13) Review and approve website updates 14) Perform other special project duties as assigned

CRITICAL REQUIREMENTS

  • Qualifications / Skills Required
    1) BS in Food Science, Life Sciences or similar (preferred)
    2) Graduate degree in Regulatory Affairs (preferred)
    3) Master’s degree (preferred)
    4) Minimum 5 years of related experience
    5) Experience in database, spreadsheet and file management
    6) Individual from natural organic food first, food second and pharma third preferred
    7) Ability to navigate and solve problems in Navision software
    8) Ability to multi-task and a team player
    9) Highly detail-oriented with a strong desire to work with variety of information
    10) Strong communication skills with the ability to communicate programs and policies thoroughly
    11) Efficient data entry and database management skills
    12) Great deal of flexibility and time management skills
    13) Intermediate Excel skills
    14) Strong organization skills

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:
Experienced - Not Management
Function:
  Quality,  Compliance
Preferred Industry Background:
  Pharmaceuticals
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation:
A superb base salary and bonus structure are available; compensation is commensurate with experience and will be discussed with qualified candidates only.