Manager Advertising and Promotion US Regional

Viatris; Washington (District of Columbia); On-site; USD 120,000 - 160,000; Full time

Job summary

Viatris seeks a Manager Advertising and Promotion Regulatory Affairs to lead US regulatory strategy for promotional materials and labeling, ensuring compliance with FDA rules. You will coordinate with cross-functional teams including Commercial and Clinical Affairs, and serve as the regulatory liaison with the FDA on PRC matters.

The role requires familiarity with DDMAC/OPDP processes, lifecycle management input, and proactive risk assessment to support commercial growth while safeguarding

Qualifications

• Bachelor's degree and 2–4 years of experience; BS in Pharmacy or Nursing with 5 years A/P RA or 5–7 years cross-functional regulatory experience preferred.
• Knowledge of US pharmaceutical marketplace and medical terminology required.
• Experience supporting regulatory review of promotional materials and interactions with DDMAC or OPDP.
• Ability to balance projects with day-to-day duties and manage priorities.

Responsibilities

• Provide US regulatory expertise for FDA advertising, promotion, and labeling activities for Viatris' sales and marketing initiatives.
• Oversee implementation of regulatory objectives and review proposed marketing plans and actions.
• Offer regulatory leadership to Commercial, Clinical Affairs, and other functions to maximize product promotion value.
• Provide input to global organization on domestic regulatory strategies and lifecycle management.
• Coordinate, review, and follow up on regulatory submissions related to advertising and promotion.
• Build Relationship Management with FDA; coordinate with agency contacts and PRC committee.
• Provide Regulatory training for Marketing, Clinical Affairs, Sales, and other functions.
• Stay current on FDA regulations and guidance related to advertising and regulatory applications.

Skills

FDA advertising compliance

Regulatory affairs

Cross-functional collaboration

Medical terminology

Regulatory strategy

Education

Bachelor's degree in Pharmacy or Nursing

Tools

Regulatory submissions management

Job description

Mylan Pharmaceuticals Inc. Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Every day, we rise to the challenge to make a difference and here's how the Manager Advertising and Promotion US Regional role will make an impact:

The Manager, Advertising/Promotion Regulatory Affairs will be responsible for the implementation of regulatory strategies for promotion and advertising plans for NA. Assists in the development and review of regulatory strategies for promotional materials, labeling, product defense, and development projects. Provide input to the global organization across Viatris businesses for promotional labeling strategies of marketed drugs and represent RA on the PRC committee. Serves as the primary liaison with FDA OPDP and DMEPA.

Key responsibilities for this role include:

• 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

The minimum qualifications for this role are:

• 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 have experience working with cross-functional groups, which may include Medical, Legal, Marketing etc.
• Must be able to articulate risk and find creative solutions. Must have ability to understand issues, problems and opportunities by comparing data from different sources to draw conclusions.
• Must possess a strong work ethic and have outstanding organization and time management skills. Must have strong computer skills and be proficient within the Microsoft Offic