Dohmen Life Science Services

Vice President of Regulatory Compliance Consulting

US-CO-Wheat Ridge
Job ID
2017-1673
# of Openings
1
Category
Management

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 POSITION:

The most important aspect of the position of the VP of Regulatory Affairs Compliance will be having the responsibility for managing the regulatory compliance consulting service line and aspects of projects, including the preparation and submission of correspondence and applications to regulatory agencies.  The major focus of this team is auditing/conducting gap assessments/supplier qualification and oversight and leading a team of qualified auditors. This person will assign work to the regulatory compliance consulting resources and participate in business development for regulatory compliance. This person will also function as a direct contact with regulatory authorities for Denver site audits and audits of clients and will to facilitate the prompt review and approval of submissions related to audits, audit responses.  This person will develop appropriate responses to FDA 483s and Warning Letters.  This position is a member of DLSS’ Executive Management Team (EMT) as well as a member of the Management Review Team and will serve as the Management Representative for ISO/EN Certifications.

 

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 compliance aspects of projects,
  • Development of new customer projects that generate additional 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.
  • Participate in Regulatory speaking engagements as a way to actively rebrand DLSS and encourage additional market recognition
  • In conjunction with the VP, RA, the incumbent will help set the DLSS Regulatory strategy and support his group to execute against the strategy
  • 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

RESPONSIBILITES:

  • Manage and staff the Regulatory Compliance function and developing annual regulatory goals and objectives in conjunction with the DLSS EMT
  • Work as Senior 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 15years regulatory affairs experience is preferred; 10 years of regulatory affairs experience is required in the pharmaceutical industry; biologics experience a plus, medical device experience/combination product experience a plus.
  • A minimum of 10 years of FDA regulatory and quality systems experience is required
  • Incumbent must be able to operate in a highly structured environment and manage multiple projects simultaneously
  • Experience managing technical resources is highly desired

 

  Personal Skills/Attributes/Qualifications:

  • Internal and external customer focus
  • Timeliness in achieving deliverables
  • Organizational skills
  • Excellent written and verbal communication

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