The Senior Director, U.S. Regulatory Affairs Promotional Advertising will serve to ensure the compliance of promotional materials for the organizations products. This role is responsible for overseeing the development, review, and approval of advertising content, collaborating with cross-functional teams, and providing strategic leadership to integrate regulatory considerations into marketing initiatives. The Senior Director serves as the primary liaison to FDA (OPDP) on regulatory issues concerning advertising & promotional materials on assigned products.

　　Additionally, this role serves to inspire and lead a team of specialized regulatory professionals which fosters collaboration and driving a high-performance culture that aligns with our organizational goals. As the leader, the Senior Director will provide proper guidance, mentorship, and development ensuring a skilled and motivated workforce. Further, this role effectively manages and allocates resources ensuring optimization of budgetary allocations for advertising and promotional regulatory initiatives.

　　RESPONSIBILITIES

　　The following job duties are not all-inclusive and additional responsibilities may be added to the role as needed. The duties and responsibilities listed are intended to provide a general overview of the position and may change over time based on the needs of the organization.

　　Ensure U.S. advertising and promotional materials comply with applicable regulatory requirements, standards, and guidelines across all products.

　　Develop and implement regulatory strategies for advertising and promotional campaigns, aligning them with business objectives.

　　Collaborate with cross-functional teams, including marketing, legal, medical affairs, and regulatory affairs teams, to integrate regulatory considerations into promotional strategies.

　　Oversee the review, approval, and submission of promotional materials to regulatory authorities, ensuring accuracy and compliance.

　　Conduct risk assessments of U.S. promotional campaigns, providing guidance on potential regulatory risks and developing mitigation strategies.

　　Provide training on U.S. regulatory requirements for promotional activities and ensure effective communication of regulatory standards to relevant stakeholders.

　　Manage the preparation and submission of regulatory documents related to advertising and promotional materials, ensuring timely submissions.

　　Address regulatory issues and challenges related to advertising promptly, working collaboratively to find effective solutions.

　　Collaborate with cross-functional teams to facilitate market access by ensuring timely and compliant approval of advertising and promotional materials in various international markets.

　　Represent the organization's regulatory interests in interactions with health authorities, industry associations, and regulatory forums.

　　Inspire and lead a regulatory affairs team, fostering a collaborative and high-performance culture that aligns with organizational goals.

　　Provide guidance and mentorship to team members, supporting their professional development and ensuring a skilled and motivated workforce.

　　Drive continuous improvement initiatives within the regulatory affairs function, optimizing processes to enhance efficiency and effectiveness in managing advertising and promotional compliance.

　　Stay informed about U.S. regulatory trends, changes, and requirements impacting advertising and promotional activities to adapt strategies accordingly.

　　Monitor and report on the regulatory landscape, providing insights and recommendations to ensure proactive compliance with advertising and promotional regulations.

　　Other duties as assigned.

　　SUPERVISORY | DECISION-MAKING AUTHORITY

　　Will manage direct report(s) and have budget responsibilities.

　　MINIMUM JOB REQUIREMENTS

　　Bachelors degree desired in regulatory affairs within the pharmaceutical, biotechnology, or healthcare industry.

　　Minimum of 12 years of regulatory affairs experience and 5 years experience leading regulatory teams.

　　Solid understanding of regulatory requirements, particularly in the areas of advertising and promotional activities.

　　Depth of knowledge and expertise to navigate the complexities of regulatory affairs for advertising and promotional materials.

　　Ability to develop and implement regulatory strategies aligned with business goals and market dynamics.

　　Demonstrated leadership skills to lead and inspire teams, providing guidance and direction in regulatory affairs.

　　Experience with cross-functional teams and negotiating, collaborating, and managing risk.

　　Effective project management skills to oversee the development, review, and approval of promotional materials, ensuring timely submissions and compliance.

　　Ability to conduct risk assessments for promotional campaigns and develop strategies to mitigate regulatory risks.

　　Skilled in representing the organization's regulatory interests in interactions with health authorities, industry associations, and regulatory forums.

　　PREFERRED SKILLS & EXPERIENCE

　　Strong collaboration skills to work effectively with cross-functional teams, including marketing, legal, medical affairs, and regulatory teams, ensuring regulatory considerations are integrated into promotional strategies.

　　Excellent communication skills, both written and verbal, to convey complex regulatory concepts clearly to various stakeholders and to represent the organization in regulatory interactions.

　　Strong analytical and problem-solving skills, along with the ability to make informed decisions in a dynamic regulatory environment.

　　Ability to provide training on regulatory requirements for promotional activities and support the professional development of regulatory and cross-functional...

　　Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity