Job Summary

The Manager, Regulatory Advertising and Promotions position is responsible for the review and oversight of all marketing and sales training materials that constitute advertising and promotional activities for US marketed products within nutrition. The position is responsible for the management of timely submissions of all advertising and promotional materials to the FDA. The Manager, Regulatory Advertising and Promotions interprets and administers the policies, processes, and procedures necessary for the review and approval of marketing and sales training materials in collaboration with the market unit. Maintains effective working relationships with legal, Medical Information and Safety, Marketing, Communications and RA teams. Participates in management discussions, provides strategic guidance for Ad Promo review, compilation, and submission according to FDA regulations.

• Salary Range: $110,000-125,000
• Position is eligible to participate in an annual bonus plan with a target of 10% of the base salary.
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

• Function as the expert within the job function and the product/disease state.
• Review and approve advertising and promotional materials, corporate and other non-promotional communications/materials as applicable, for all US marketed products-primarily Parenteral Nutrition products and support other pharmaceutical drug products as needed. 
• Oversight could also include AdPromo materials for in licensed products as well as partnership products where FK holds the application but doesn’t market.
• Responsible for operational leadership to ensure compliance with current FDA regulations and expectations and consistency in regulatory decisions concerning marketing materials. Decisions include appropriateness of materials, amount and placement of safety information, eligibility for submission, bundled strategies, multimedia materials, etc.
• Assume a leadership role in advising cross-functional stakeholders on the regulatory impact of new campaign concepts and may also be required to provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications.
• Develop regulatory strategy and FK philosophy around advertising and promotional materials for US products.
• Provide regulatory intelligence and education on emerging regulations and trends in the Advertising and promotional space including reviewing and interpreting enforcement letters. Provide comments and perspective on proposed regulations. Anticipate changes in the regulatory environment and the potential impact to FK, shaping internal strategies accordingly.
• Develop process for tracking and grouping/planning of OPDP submissions to improve operational efficiency and potentially reduce review time on future materials
• Develop and provide training for individuals involved in content creation of advertising and promotional materials.

Job Requirements

• Bachelor’s degree in life sciences / medical discipline. 
• 5+ years of related experience in the pharmaceutical industry, including but not limited to regulatory affairs experience.
• 3+ years of experience in US regulatory affairs advertising and promotional review.
• Thorough understanding of US regulations for drug promotion/advertising and experience in the regulatory review of prescription drug advertising and promotion including product launches for biologic/biosimilar products.
• Demonstrated effective written and verbal communication skills, attention to detail, and superior organization skills.
• Demonstrated experience in working with others collaboratively to achieve organizational objectives including the ability to lead and influence decisions, anticipate and adapt, work tactics to support changing business needs.
• Proven ability to analyze and interpret efficacy and safety data.
• Proficient in standard business software applications and an aptitude for electronic systems and software.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.