Responsibilities

• Provides the US regulatory expertise for FDA advertising, promotion, and associated labeling activities for Viatris’ sales and marketing initiatives. As a PRC team member, provide proactive promotional strategies, tactics and reviews so that the company can meet both short and long-term growth targets and adhere to regulatory requirements.
• Oversee and bear responsibility for the successful implementation of regulatory tactical objectives and projects. Identifies product specific issues and recommends proposed marketing plans and proposes an acceptable course of action. Suggests regulatory strategy and provides supporting information to address issues.
• Provides regulatory leadership to internal constituencies (Commercial, Clinical Affairs, etc) to maximize the competitive impact of product development as well as ultimate promotion, advertising and reimbursement. Actively participates in the development of brand plans and strategic imperatives.
• Provides input to the global organization on domestic regulatory strategies through life cycle management programs. Identifies and provides product specific regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders.
• Coordinates, reviews, prepares and, as necessary, follows up on required regulatory submissions related to advertising and promotion.
• Implement Relationship Management initiatives with FDA; partners with Commercial and Clinical Affairs to coordinate agency contacts and harmonize activities. Acts as a regulatory representative/liaison on PRC review committee.
• Provides Regulatory training for Marketing, Clinical Affairs, Sales, and other functions and partners.
• Remains current on FDA regulations and guidance associated with advertising, promotion, and regulatory applications. Demonstrates role specific Competencies and company values on a consistent basis.
• Understands Regulatory’ s overall objectives and how the role adds value to product teams.
• Performs related duties as requested

Requirements

• Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience.
• Bachelor of Science in Pharmacy or Nursing with 5 years of A/P RA experience or 5-7 years cross-functional regulatory experience preferred.
• Related experience and/or education may be considered.
• Knowledge and understanding of complex medical and scientific subject matter is required.
• Must have a strong understating of the U.S. pharmaceutical marketplace and familiarity with medical terminology.
• Must have previous experience in supporting regulatory review of promotional materials and interacting with DDMAC or OPDP.
• Must be able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed.
• Ability to establish priorities and timelines to effectively manage workload and multi-tasking is essential.
• Demonstrated history of proactive A/P strategies and tactics is required.
• Must be able to work independently and develop collaborative relationships to facilitate the accomplishment of work goals.

Preferred

• Bachelor of Science in Pharmacy or Nursing with 5 years of A/P RA experience or 5-7 years cross-functional regulatory experience preferred.

Benefits

• At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.