Medical Device company has an immediate need for a Consultant of Regulatory Affairs-Global Advertising and Promotions. Responsible for the review of Advertising and Promotional (Ad Prom) material and accountable for all operational aspects of regulatory submissions providing planning and technical support for Company's products for one or more business units/countries. This is a contract position expected to last 2 years, could be longer based on performance, possible temp to hire. Apply Now!
location: Round Lake, Illinois
job type: Contract
salary: $70 - 90 per hour
work hours: 8am to 5pm
Essential Duties and Responsibilities
- Review and approve advertising and promotional material
- Initiate, manage and maintain operational activities in support of new and existing marketing authorizations
- Plan and manage complex projects and prioritize workload
- Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Company and external standards
- Maintain appropriate communication within the RA function, SBU marketing, and other functions primarily at the project team level
- Communicate proactively and report to regulatory authorities
- Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks
- Assess impact of new regulations and provide feedback.
- Set team, group, or service objectives to assure they align with the Regulatory strategy
- Provide technical and strategic input for regulatory decisions
- May manage budget at country level
- May provide direct supervision of individuals including mentoring, performance management and staffing decisions
- Minimum of 8 years of experience in Regulatory Affairs Advertising & Promotion, including managing people or projects. Higher degree/PhD will be an advantage.
- Expert Regulatory knowledge in the Ad Prom space and other Regulatory functions
- Scientific knowledge
- Strong ability to work with cross-functional teams
- Ability to oversee multiple projects in a matrix team environment.
- Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities.
- Excellent oral and written communication and presentation skills.
- Ability to accomplish results through others
- Great Communicator
- Work well on cross functional teams
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.