Dohmen Life Science Services

Director Regulatory Affairs Consulting

US-CO-Wheat Ridge
Job ID
2017-1785
# of Openings
1
Category
Consulting

Overview

OUR COMPANY:

 

Since 1858, Dohmen has been driven by the desire to get safe and effective treatments and cures to the people that need them most.  As entrepreneurs, we’ve looked for new and better ways of doing this year after year. Today, as Dohmen Life Science Services, we bring the industry’s most comprehensive service array to Medical Device, Biotech and Pharmaceutical entrepreneurs, helping them get farther faster and keeping them focused on innovations that improve lives. 

 

Our behavior is guided by five simple values –

Caring: We are empathetic and respectful.  We ask “how can I help you”

Committed: We are dedicated and persistent.  We ask “how can I make it happen”

Creative: We are inventive and imaginative. We ask “how can I do it better”

Collaborative: We are cooperative and share our knowledge. We ask “how can we achieve success” 

Courageous: We’re willing to risk failure over inaction. We ask “how can I challenge myself”

This perspective defines us. How we act, how we do business, how we work with our clients and how we work with each other. They are essence of what makes us successful. They are what set us apart. 

 

THE POSITIONVIRTUALLY BASED

 

The Director of Regulatory Affairs will have the responsibility for managing the regulatory compliance service line and aspects of projects, including the preparation and submission of correspondence and applications to regulatory agencies. This position is a billable position and will be a member of DLSS’ Executive Management Team (EMT) as well as a member of the Management Review Team.

 

This role will be responsible for global development strategies and the individual will be able to choose where the position will be based. 25-30% travel to clients as needed.

 

POSITION SUCCESS FACTORS:

  • Ability to set a regulatory compliance consulting strategy
  • Ability to act as senior regulatory affairs consultant
  • Ability to work with internal employees and external clients simultaneously
  • Ability to manage multiple projects and deliverables in a timely fashion

            ESSENTIAL FUNCTIONS:

  • Managing the regulatory compliance service line which will involve a large use of 1099 resources. ALSO work as a Senior Regulatory Consultant managing the regulatory aspects of projects, including complex applications submitted to various regulatory agencies.
  • Development of new customer projects that generate additional Regulatory and Regulatory Compliance work as well as developing existing customer relationships leading to additional revenue, profit and referrals
  • Ensuring that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements.
  • Developing strategic regulatory approaches for projects, as appropriate with very limited oversight.
  • Preparing and writing complex submissions and other regulatory filings as required.
  • Planning and conducting formal meetings and teleconferences with regulatory authorities.

 

 

Responsibilities

RESPONSIBILITIES:

    • Manage and staff the Regulatory Compliance function and developing annual regulatory goals and objectives in conjunction with the DLSS EMT
    • Work as Regulatory Affairs Consultant in the regulatory strategy and projects group
    • Managing, training and mentoring regulatory associates and/or quality specialists

     

Qualifications

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

  • Bachelor’s degree in a related discipline with a minimum of 8 years regulatory affairs experience is preferred; 10 years of regulatory affairs experience is required in the pharmaceutical industry; biologics experience a plus.

 

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