Senior Manager, Commercial Regulatory Affairs
The Opportunity: Senior Manager, Commercial Regulatory Affairs
Serves as a primary or secondary regulatory advertising and promotion reviewer for assigned products on MLR teams with oversight.
Manage regulatory submissions of promotional materials as required (e.g., FDA Form 2253) and interact with health authority stakeholders when applicable.
Interpret evolving regulatory requirements and enforcement trends to proactively guide commercial strategy and risk assessments.
Train and advise cross-functional teams on commercial regulatory compliance, MLR process and best practices.
Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical/biotech companies published by OPDP or APLB, and by attendance of major FDLI, DIA and other industry meetings.
Ensures that changes in US Prescribing Information are reflected in current promotion and advertising.
Participate in the development and maintenance of MLR operational objectives, policies, and procedures.
Bachelor's Degree in a relevant field with 5+ years relevant experience.
8+ years of relevant promotional regulatory affairs experience in the biotech or pharmaceutical industry for the US market.
Strong understanding of FDA regulatory requirements governing promotional activities and experience managing promotional submissions and reviews.
Strong, current understanding of scientific exchange and pre-approval discussions; ability to unpack and deploy these concepts in practice.
Track record of influencing cross-functional decisions and operating with sound regulatory judgment.
Excellent communication skills and ability to work collaboratively across teams.
Collaborative and solution-oriented mindset and approach.
Exemplary compliance ethics and high concern for standards.
Advanced degree in a relevant field.
Experience in oncology therapeutic areas.
Experience with product launches.
Recommended Jobs
Appointment Setter
**Company:** Venture Smarter **Location:** Work From Home **Position Type:** Full-Time ### **&##128188; About the Role** Venture Smarter is seeking a motivated and professional **Appointment Set…
Senior Embedded Software Engineer (Bare Metal)
ABOUT THE TEAM Anduril Intelligence Systems (AIS) is focused on positioning Anduril as a lead provider of specialized engineering and products for Intelligence Community (IC) customers. We work …
Compliance Professional
The Riot Compliance team is committed to providing the highest quality compliance services that align with Riot's mission of putting players first. Every project we manage, every audit we conduct, an…
Class A Truck Driver
Clean driving record Pay will be negotiable depending on experience Interview prior to starting Valid driver license Must be open from making commute from Perris area to LA area Drivin…
Senior Lead Data Engineer (R4680)
Founded in 2015, Shield AI is a venture-backed deep-tech company with the mission of protecting service members and civilians with intelligent systems. Its products include the V-BAT and X-BAT aircra…
Bowling and Events Associate
Are you into video games, bowling, or karaoke? Are you friendly, and outgoing? Do you enjoy being around people and working in a fun environment? Then you’re the kind of person we’d love to hire. …
Tax Senior (Los Angeles)
Tax Senior- Top Ranked LA Firm + Life Balance! This Jobot Job is hosted by: Josh Forth Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $80,…
Founding Engineer - Full Stack
The Company Datawizz helps companies reduce LLM costs by 85% while improving accuracy by over 20% by combining distillation, model routing, and pruning to route requests to smaller, more efficient m…
Mainframe Systems Programmer
Apogee Global RMS is looking for a Senior Mainframe Systems Programmer who will be responsible for installing, configuring, maintaining, and optimizing z/OS mainframe environments that support missio…
Senior Software Engineer, Embedded C/C++ Flight Software
ABOUT THE JOB At Anduril, our Software Engineers are at the forefront of defense technology, crafting high-impact, cutting-edge solutions that redefine innovation. You'll dive into a diverse ran…