Director of Regulatory Affairs

Sterling-Hoffman Executive Search Located in: Virginia
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JOB DESCRIPTION

Our client, a leading life sciences consulting company, is currently seeking an accomplished Director of Regulatory Affairs to join the team. Here is an overview of the role:

1) Provide strategic guidance to clients to ensure that developmental activities are effective and the regulatory documentation comply with relevant regulations, guidelines, and industry standards
2) Draft and review all sections of IND and NDA filings
3) Develop and manage overall regulatory project timelines
4) Supervise and guide cross-functional project team professionals and support personnel
5) Contribute to the development and implementation of procedures and policies for regulation of marketed promotional materials
6) Develop strategies for regulatory approval and introduction of new products to market
7) Manage the process from development of regulatory strategies through to approval
8) Prepare and submit submissions and ensure compliance with all regulatory requirements pertaining to product approval
9) Ensure that all regulatory-related policies and procedures are current in accordance with applicable regulations and standards
10) Provide regulatory guidance and support to project teams, including regulatory filing strategies, testing and standards requirements

CRITICAL REQUIREMENTS

  • 1) A university degree is required (preference will be given to those with degrees in a relevant field, though all candidates are welcome and encouraged to apply)
    2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    3) Recent experience in the life sciences consulting industry is strongly preferred
    4) Preference will be given to people with recent experience in regulatory affairs management

    This is an amazing opportunity for someone with a great attitude who isn’t afraid to roll up their sleeves and get things done. Our client believes in adding value to each and every thing they do and is looking for someone with similar values.

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
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: