Director, RA, Advertising & Promotion

 

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary:

The Director, Regulatory Affairs, Advertising & Promotion is responsible for strategic direction and regulatory compliance on all product claims by providing sound regulatory advice that minimizes the risk of regulatory and legal action, competitively positions marketed products, and is consistent with applicable global regulations and West corporate policies.  This role serves as a key strategic partner with the R&D, Clinical, QA, Operations, Commercial, and Legal teams and works directly with the broader regulatory matrix team to ensure compliant product claims. In addition, the Director provides support for US, EU and ROW clinical programs and regulatory approvals in compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This role is responsible for driving continuous improvement in the day-to-day operations of the regulatory and quality functions and seeks opportunities to continually enhance cross-functional effectiveness across the organization in line with corporate goals. They must proactively maintain an understanding of health authority guidelines, regulations, and best practice to establish regulatory strategy and shape the future regulatory requirements.

 

Essential Duties and Responsibilities:

• Provide strategic regulatory expertise and operational direction to management, internal, and external customers to ensure conformance with corporate requirements, government regulations, guidelines and industry standards as it relates to promotional compliance and product claims.  Develop clear policies, processes, and trainings to embed a culture of regulatory compliance within West and with our partners.
• Serve as internal expert and primary regulatory reviewer/approver for all externally facing West content (website, publications, presentations, blog posts, partner content, etc.) to ensure compliance with applicable global regulations, policies, and guidance.
• Lead efforts to proactively understand and embed the latest global regulations, guidance, and enforcement trends for advertising and promotional labeling.  Direct, advise, and guide Regulatory Affairs and cross-functional leadership on regulatory strategies and impact to the West business.
• Evaluate and assess claims generation strategies for new products, leveraging scientific knowledge and substantiation criteria
• Develop and conduct training for internal and external stakeholders as needed to maintain compliance with evolving regulatory requirements
• Provide strategic input to product development and commercial teams to support flexible and viable claims strategies while championing promotional compliance
• Identify and qualify vendors, tools and systems to build efficiency for promotional material reviews and collateral lifecycle management. 
• Adhere to all applicable government and West