Director, Regulatory Affairs

Overview

The Director, Regulatory Affairs for U.S. Advertising and Promotion (USAP) will provide strategic regulatory advice to internal stakeholders regarding tactics and communications related to Alnylam's marketed products, investigational treatments, and disease areas to healthcare providers, patients, payers, and other audiences. A critical aspect of this role is to enable achievement of business objectives while ensuring compliance with U.S. laws and regulations and Alnylam policies. The Director, Regulatory Affairs (USAP) will help build the USAP team and capabilities and may be responsible for supervising or mentoring more junior team members and fostering their professional development. The Director, Regulatory Affairs (USAP) will report to the Senior Director of U.S. Advertising and Promotion.

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

Key Responsibilities

• Collaborate with colleagues in Commercial, Medical Affairs, Legal, Compliance and other expertise areas in creation of promotional and disease awareness communications, field training materials, and materials and communications used in scientific exchange, for assigned product(s)
• 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
• Support achievement of corporate goals by using flexible and innovative approaches while appropriately mitigating risk
• Serve as internal expert on 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
• Experienced in managing individuals and/or teams preferred
• 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

U.S. Pay Range

$190, $257,500.00

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website:

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.