Sr. Regulatory Affairs Manager in Advertising and Promotion (Ad Prom)
job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed!
location: Deerfield, Illinois
job type: Contract
salary: $65.00 - 77.72 per hour
work hours: 9 to 5
- Review promotional material and provide Regulatory guidance to cross-functional teams
- Interface with cross-functional teams to help execute commercial campaigns and launches
- Participate in and support functional projects or business initiatives of low to medium complexity
- Assess impact of new regulations and provide feedback and provide recommendation upon request
- Communication with regulatory agencies with oversight
- Maintain appropriate communication within the RA function, GBU Marketing and other functions primarily at the project team level
- Initiate, manage and maintain operational activities in support of new and existing marketing authorizations
- Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Company and external standards
- Evaluate technical and scientific information, identify deficiencies, and make recommendations to remediate risks
- Provide technical and strategic input for regulatory decisions
- Influence commercial acceptance of regulatory assessments, with manager input and oversight.
- Attend conferences and industry events for development purposes
- Craft IRI (important risk information) as appropriate with label changes, with guidance from manager. Specifically for Promotional Labeling experience, and not just labeling experience.
- Minimum of Bachelors degree or country equivalent in related scientific discipline
- Minimum of 8+ years regulatory specifically in advertising or promotions.
- Minimum of 3+ years of leadership experience.
- Experience reviewing U.S. FDA Submissions for accuracy
- Expert Regulatory knowledge as it pertains to advertising and promotion regulations in the US or Globally
- Expert in Global or US Regulatory Affairs Advertising and Promotion for either drug or devices.
- Scientific Knowledge
- Ability to participate in cross-functional projects while prioritizing day to day responsibilities
- 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
skills: FDA, GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Briefing Documents, Submissions
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.