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Sr. Director of Regulatory Affairs

SRG Woolf Group

Boston, Massachusetts
Job Status:
Full Time
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Job Details

A Bio pharmaceutical company is seeking a Sr. Director of Regulatory Affairs to join their team in the Boston metro area. This is a fantastic opportunity with a growing client. If you are seeking a senior leadership role that will allow you to utilize your Regulatory Affairs expertise to develop and guide the team this is the opportunity.

PURPOSE OF POSITION: The Sr. Director of Regulatory Affairs is responsible for the overall planning and leadership of clinical regulatory activities while creating and establishing strategies in an effort to obtain approval of regulatory submissions.

EDUCATION/SKILLS: Bachelor’s degree in a Scientific area is required however an advanced degree or Regulatory Affairs Certification is preferred. Also seeking a 8+ years of clinical regulatory affairs experience along with leadership/management responsibilities is requested. This role will oversee planning of regulatory submission activities, implements strategies, negotiates with outside agencies to resolve issues, monitors budget and program costs and assists in the publishing of regulatory submission such as INDs, NDAs and IMPDs. CMC experience preferred! These are some highlights of skills needed however not all inclusive.

SRG Woolf is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

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