Regulatory Affairs Associate

Sterling-Hoffman Executive Search Located in: Oregon
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JOB DESCRIPTION

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

1) Track the committed timeliness and follow up with the internal departments proactively for required documents
2) Organize and maintain submission components associate with a regulatory submission electronically
3) Screen the abbreviated new drug applications against the abbreviated new drug application checklist, in order to avoid screening queries
4) Maintain regulatory databases up-to-date and as per the set criteria
5) Maintain current knowledge of regulations and other issues that affect products and industry
6) Work with colleagues in resolving regulatory issues and problems
7) Archive and maintain all submissions in a systematic way
8) Perform administrative functions as directed by management, in order to support projects and to ensure the smooth operation of the department
9) Ensure compliance with standard operating procedures to archive regulatory submissions and correspondence in internal document management systems
10) Interact effectively with functional business units, in order to coordinate documentation required for submissions

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

    If you are qualified and believe you have the ability to excel in this role, this could be your opportunity to work with an excellent and respected company in the pharmaceutical industry. 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:
Experienced - Not Management
Function:
  Regulatory Affairs
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: