Senior Specialist, Regulatory Affairs (Advertising and Promotion) - SPCSHP

SPCSHP is an Agency of Progress, applying intelligence, creativity, and craft to help clients understand themselves, their customers, and the larger culture. Regardless of the size of the organization or where they are on their journey, they all must move forward. For some, this requires incremental change. For others, transformation. SPCSHP is designed to build brands the way people experience them – where Stories, Systems, and Communities meet. Our client relationships span different industries and brand life stages: from start-ups like Lightricks to established Fortune 500 companies like JPMorgan Chase, Dairy Queen, PepsiCo, and Starbucks, among others.

The Senior Specialist, Regulatory Affairs (Advertising and Promotion) will support the promotional material review and approval process for advertising created at SPCSHP. The Senior Specialist will be responsible for managing all legal and regulatory submissions related to healthcare and pharmaceutical advertising campaigns. This role requires expertise in the submission requirements and platforms for healthcare products, with a strong understanding of FDA regulations and advertising guidelines. You’re a critical thinker with the ability to master new systems and become the submissions expert for assigned brands.

Requirements

• Serve as day-to-day submissions lead and act as a subject matter expert on constantly evolving client submission requirements and platforms
• Act as a subject matter expert (SME) on client submission requirements and platforms, staying informed about the constantly evolving landscape of regulatory requirements.
• Demonstrate general knowledge of Regulatory Affairs and guidelines that govern advertising and promotional material according to FDA
• Work cross functionally with Project Management to ensure submission timelines are met and all material is gathered for accurate and timely submissions
• Collaborate with Creative teams during creative brainstorms to help shape ideas and ensure compliance with guidelines
• Coordinate with Account and Client Service teams to ensure that submissions meet both client expectations and internal quality standards.
• Develop departmental processes and documentation to conform with client and SPCSHP guidelines
• Continuously monitor industry trends and changes in regulatory requirements to ensure agency compliance and anticipate potential challenges.
• Keep an updated record of all best practices and training materials for the assigned brand(s)
• Establish and manage role as primary point of contact with client MLR liaison
• Follow up with client liaison in a timely manner to ensure the submission is received on time and meets 100% of client expectations and specifications
• Actively review and assess materials for regulatory compliance before submission, ensuring adherence to FDA and client-specific legal guidelines.
• Assist in identifying and mitigating potential regulatory risks during the development of promotional materials.

Skills & Qualifications

• Minimum of a bachelor's degree and 5 years of experience in the preparation of complex deliverables under tight deadline constraints is required
• At least three years of experience in Pharmaceutical Industry, Healthcare, or Advertising Agency is required.
• Familiarity with agency submission process and MLR preferred
• Experience communicating with clients directly is required.
• Demonstrated knowledge of FDA pharmaceutical advertising regulations through appropriate training or previous experience is preferred.
• Strong attention to detail and ability to manage multiple submissions simultaneously in a fast-paced environment.
• Exceptional written and verbal communication skills, including technical writing, ensuring that all documentation and communication is clear and accurate.
• Ability to work both independently and collaboratively across departments to meet deadlines and maintain high standards of work.
• Strong organizational and problem-solving skills with a proactive approach to managing issues and challenges.
• Experience in Veeva Vault PromoMats.

The salary band for this role is $120,000 - $140,000. Where a prospective new hire's base salary will fall within this band depends on several factors including their qualifications and experience, the skill level required in the role, market rates, and the salaries of existing crew members at SPCSHP within the same role to maintain equity.