Copy of AH - Italy Test

Overview

The Director, Regulatory Affairs for U.S. Advertising and Promotion (USAP) will provide strategic regulatory advice to internal stakeholders, primarily regarding direct-to-consumer (DTC) tactics related to Alnylam’s marketed products, investigational treatments, and disease areas. The ideal candidate will have prior experience supporting products within a competitive treatment landscape and providing strategic guidance for product broadcast advertisements, digital and social media tactics, media activities, and product spokespersons.

A critical aspect of this role is to enable achievement of business objectives while ensuring compliance with applicable U.S. laws and regulations and Alnylam policies. The Director, Regulatory Affairs for USAP may be responsible for mentoring more junior team members and fostering their professional development. The Director, Regulatory Affairs for USAP will report to the Senior Director of USAP.

*This a hybrid role based in our Cambridge, MA or Philadelphia, PA office. 

 Key Responsibilities

• Collaborate with colleagues in Commercial, Medical Affairs, Legal, Compliance and other expertise areas in creation of promotional and disease awareness communications, and field training materials for assigned product(s)


• Provide balanced risk perspectives and top-quality regulatory advice in a highly regulated market to internal stakeholders that reflects knowledge of historic and evolving enforcement trends


• Serve as Regulatory Reviewer on Commercial and Medical Review Boards for assigned product(s)


• Act as Alnylam’s liaison to the FDA’s Office of Prescription Drug Promotion (OPDP) for assigned product(s), including preparing correspondence for advisory comment submissions and conducting negotiations, if applicable


• Support achievement of corporate goals by using flexible and innovative approaches while appropriately mitigating risk


• Serve as internal expert on applicable U.S. laws and regulations, FDA guidance documents, and enforcement actions


• Contribute to culture of compliance at Alnylam by educating colleagues on the regulatory framework and environment, providing assessment of risk for proposed communication tactics and strategies, and participating in development of policies and procedures


• Monitor new or revised legislation, regulations, guidance documents, industry standards, and enforcement actions related to promotional communications, disease awareness, scientific exchange, and human subject protection, and analyze and communicate their relevance to Alnylam


• Provide advice regarding clinical study design elements and labeling needed to support target product profiles and desired commercial claims


• Help build USAP team and capabilities, including development of processes and best practices


• Work closely with Regulatory Operations in making timely submissions of promotional materials to FDA

Qualifications

• BS/BA degree; advanced degree desirable but not required


• 10 years of relevant professional experience, including at least 5 years in Regulatory Affairs in a U.S. advertising and promotion role


• Expert in U.S. law, regulations, and FDA guidance documents related to communications about prescription drugs, investigational treatments, and disease education


• Experience with a product launch or launches and in communicating with OPDP or APLB, including submissions for advisory comment, highly desirable


• Prior experience in supporting products for prevalent diseases a plus


• Demonstrated understanding of the importance of clinical study design and statistical principles and analyses to assessment of permissible claims


• Highly skilled in written and verbal communications, including a facility for understanding and communicating scientific, medical, and legal concepts and information


• Must be comfortable providing recommendations and making decisions in areas that are often “gray.” 


• Able to influence without authority in a matrix environment


• Strong interpersonal skills, with ability to collaborate across disciplines to solve problems