Senior Director of Regulatory Affairs and Clinical Development

Sterling-Hoffman Executive Search Located in: Tennessee
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JOB DESCRIPTION

Our client, a leading pharmaceutical company, is currently recruiting a Senior Director of Regulatory Affairs and Clinical Development who will infuse the Regulatory Affairs team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Responsibilities include:

1) Design and implement clinical studies and prepare pre-approval and post-approval regulatory submissions
2) Encourage and develop a multi-disciplinary team to achieve key objectives
3) Design, execute and report clinical trials across all phases of development
4) Achieve successful product approvals by developing overall clinical strategies
5) Act as a point-of-contact between the company and the FDA
6) Develop a positive organizational culture by promoting values that focus on patients, science and people
7) Supervise clinical and regulatory activities for projects and coordinate departmental activities
8) Supervise company’s medical call center and pharmacovigilance activities
9) Supervise the regulatory reviews of marketing materials
10) Polish presentations on product development activities to Board and Investment Community

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 and clinical development management

    For the right leader, this is a wonderfully rewarding role with tremendous growth prospects. If you are qualified and think you're a strong fit for this role, please apply ASAP. We thank all applicants, but only candidates who meet our client's criteria will be contacted.

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: