At Dohmen Life Science Services, an EVERSANA Company, we are committed to keeping our clients for life, ensuring no conflict of interest exists, achieving continuous innovation, and focusing on continuous improvement. Our behavior is guided by five simple values that define how we work and are the essence of what makes us successful:
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?”
The most important aspect of the position of the Regulatory Affairs Director will be having the responsibility for managing the regulatory aspects of projects, including the preparation and submission of correspondence and applications to regulatory agencies. This person will function as a direct contact with regulatory authorities to facilitate the prompt review and approval of submissions. 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.
⦁ Managing the regulatory aspects of projects, including complex applications submitted to various regulatory agencies.
⦁ 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.
⦁ Planning and conducting formal meetings and teleconferences with regulatory authorities.
⦁ Developing annual regulatory goals and objectives in conjunction with the DLSS EMT
⦁ Managing, training and mentoring regulatory associates and/or quality specialists
POSITION SUCCESS FACTORS:
⦁ Ability to work with internal employees and external clients simultaneously
⦁ Ability to manage multiple projects and deliverables in a timely fashion
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
⦁ Bachelor’s degree in a related discipline with a minimum of 10 years regulatory affairs experience is preferred; 5 years of regulatory affairs experience is required.
⦁ A minimum of 5 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
⦁ Internal and external customer focus
⦁ Timeliness in achieving deliverables
⦁ Organizational skills
⦁ Excellent written and verbal communication