Director of Software Solutions creating sales strategies and enhancing software offerings at Border States. Leading teams, managing key relationships, and driving digital transformation efforts.
About the role
- Senior Director/Executive Director overseeing regulatory advertising and promotion for biopharmaceuticals. Leading strategic initiatives, compliance, and team development in a hybrid role.
Responsibilities
- Lead the development and implementation of regulatory advertising and promotion strategies for preapproval and marketed products across therapeutic areas
- Serve as the primary reviewer, or provide oversight of the primary Regulatory Affairs representative(s) on promotional Medical/Legal/Review (MLR) committees, ensuring clear guidance and timely feedback to internal stakeholders
- Partner with senior Commercial and Legal leaders to align promotional initiatives with evolving FDA and OPDP requirements
- Ensure a strategic lens is leveraged in regulatory reviews to balance the business needs
- Provide interpretation of FDA regulations, guidance documents, and enforcement actions related to promotional labeling, advertising, and digital communications
- Oversee the review and approval of promotional materials, ensuring scientific accuracy, fair balance, and alignment with approved labeling
- Provide training initiatives on regulatory promotional compliance and regulatory principles
- Establish work instructions and SOPs for regulatory advertising and promotion
- Serve as the regulatory point of contact for FDA’s Office of Prescription Drug Promotion (OPDP)
- Prepare and lead responses to FDA requests or inquiries on advertising and promotional matters
- Monitor enforcement trends and emerging regulations, proactively adjusting company strategies and SOPs as needed
- Hire, coach, and mentor regulatory professionals supporting advertising and promotion activities
Requirements
- Advanced degree in a scientific discipline (PharmD, PhD, or MD) required
- 15+ years of progressive regulatory experience in the biopharmaceutical industry, with at least 10 years focused on pharmaceutical advertising and promotion
- Demonstrated expertise in using regulatory systems (e.g., Veeva Vault, RIM) and developing process governance frameworks (SOPs, WIs, desk procedures)
- Track record of leading or enabling digital transformation or AI integration within regulatory or adjacent functions
- Exceptional leadership, communication, and influencing skills, with the ability to operate effectively in a matrixed, fast-paced environment.
Benefits
- Market leading compensation
- 401K with 100% employer match on first 3% & 50% on the next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award for hired referrals
- Comprehensive health care with 100% premiums covered - no cost to you and dependents
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- Hybrid work model - employees have the autonomy in where and how they do their work
- Unlimited flexible paid time off - take the time that you need
- Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
- Flex spending accounts & company-provided group term life & disability
- Subsidized lunch via Forkable on days worked from our office
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