Jobs

Senior Director, Regulatory Affairs

  • Morristown, NJ
  • Direct Hire
  • Job ID: BN38-2702405

$1 to $2 Per Year

Senior Director, Regulatory Affairs

If you want to be a part of a team that is passionate and dedicated to saving lives threatened by the global public health crisis of bacterial infection s- Our company may be the right place for you. We strive to offer a dynamic work environment in which innovation, teamwork, knowledge, and flexibility are valued.

Our novel antibiotics portfolio has the unique ability to provide providers and patients with a range of solutions that can meet the tremendous need for treating serious infections. Our portfolio also encourages the use of our products at various call points within the hospital or account ecosystem, including long term care hospitals and various types of infusion centers.

Job Purpose

The Senior Director, Regulatory Affairs develops regulatory strategies for products, and oversees life cycle management of approved products while maintaining compliance with applicable regulatory requirements. Responsible for interaction with regulatory bodies to enable timely and appropriate regulatory decisions.

Duties and responsibilities

  • Provide strategic and operational regulatory direction and serve as the primary point of contact with FDA, internal teams, and global partners on specific company productsincluding but not limited to: general regulatory strategies, regulatory requirements for clinical studies and marketing approval, regulatory strategic development plans and risk assessments, critical issue management and advice on health authority interactions.
  • Lead preparation, review, and collection of documentation and tracking for all submissions to regulatory agencies, including IND and NDA submissions (Annual Reports, Meeting Requests).
  • Assist or responsible for those submissions (prior writing experience a plus)
  • Responsible for developing, updating, and maintaining labeling documents throughout the product life cycle, including Company Core Data Sheets (CCDS) and Structured Product Labeling (SPL) listing information.
  • Support regulatory filings made by global partners for out-licensed partners.
  • Work closely with Commercial, Quality, and Supply Chain, to provide regulatory guidance as it relates to promotional labeling and primary and secondary packaging requirements.
  • Provide regulatory input into business development activities.
  • Serve as the Regulatory Affairs representative on project teams; assure the progress of projects by providing direction, solutions, and feedback to the teams.
  • Timely respond to regulatory authority and business partner questions and outreach. 
  • Research and understand regulations/guidance and assesses impact on regulatory strategies; communicate these impacts with recommendations to project teams.
  • Train and develop an effective regulatory team both via direct and indirect reporting structure.

Qualifications

  • Full lifecycle experience from early development to managing marketed products
  • Strong project management and computer skills (including Microsoft office)
  • Demonstrated strong leadership and management skills; proven ability to work with very little guidance/supervision with a proactive approach
  • Experience with infectious disease products preferred
  • Global regulatory exposure preferred
  • Knowledge of Global Labeling Guidance, Drug Development and Commercialization of prescription medicines
  • Highly collaborative and works with ease in matrix environment
  • Minimum of 10 years pharmaceutical experience, 8 years regulatory experience with both development and marketed products

 

Education

Bachelor's degree or equivalent in life sciences or related discipline

Position Type / Expected Hours of Work

Full Time

Travel

As needed, approximately 10%

Apply Online
Job Alerts

Login to create notifications on the jobs you’re looking for!

Have any questions?

Let’s get in touch

  • Upload Resume
  • Max. file size: 300 MB.
  • "If you would like immediate nation-wide exposure to several thousand recruiters within our recruiter network please upload resume here and start your job search."
    Click here
  • This field is for validation purposes and should be left unchanged.
Share?

Share on popular social media

Related Jobs

Share our job with others