Application deadline:Location: Madison 07940, New Jersey, United States
Contract type: Permanent
Job ID: 4767
Role DescriptionAre you a leader who thrives at the intersection of compliance, strategy, and innovation? Join LEO Pharma and help shape impactful promotional communications that meet FDA standards while advancing business goals.
Your Role: The Director, US Reguatory Advertising and Promotion oversees and guides the development of advertising and promotional materials, ensuring they meet U.S. regulatory standards while supporting clear, truthful, and compliant communication that aligns with corporate and brand objectives.
This is a
hybrid role, based out of LEO's
Madison, NJ office. Your Responsibilities: - Act as a key regulatory affairs expert within the LMR team, providing expertise on regulatory strategy, process, filing, best practices, etc. in conjunction with leadership.
- Provide strategic and operational leadership for promotional, educational, and investigative communications
- Review and evaluate materials submitted by teams to ensure that the content, quality, and format comply with applicable laws, regulations, and client policy.
- Uses extensive knowledge of US regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support clients' corporate goals.
- Maintain knowledge of changing regulatory requirements and advise teams as appropriate.
- Represent the regulatory affairs team in other meetings or workstreams (labeling); provide support for ancillary projects.
- Interpret and apply FDA guidance documents, standards, and relevant laws.
Your Qualifications: - 8 - 10+ years pharmaceutical regulatory affairs experience within Advertising and Promotion.
- Bachelor's degree, advanced degree in a science discipline preferred.
- Broad experience across multiple therapeutic areas.
- Must have Veeva experience.
- Ability to work independently and to be innovative in tackling operational challenges.
- Team-oriented, adaptable, and effective in fast-paced, high-pressure environments.
- Self-motivated, responsible, and high-energy professional
- Must be able to perform all essential functions of the position, with or without reasonable accommodation.
Your New Team: As a member of the LMR for Spevigo, you will be interacting with all functions and business owners.
Compensation: The base salary range for this position is
$215,000 -250,000 per year. The base salary range represents the anticipated low and high of the LEO Pharma range for this position. Salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. In addition, some positions may include eligibility to earn commissions/bonus based on company and / or individual performance.
Let's pioneer together! 
