Associate Director, Regulatory Affairs, Labeling, Advertising, and Promotion

Summary

Join Orca Bio, a late-stage biotechnology company revolutionizing blood cancer treatment, as an Associate Director of Regulatory Affairs. Reporting to the Head of Regulatory Affairs, you will be responsible for developing and approving US promotional materials, ensuring compliance with regulatory guidelines. You will also lead and contribute to post-approval regulatory submissions. This role requires extensive experience in the biotech/pharmaceutical industry, specifically in regulatory advertising and promotion. Cross-functional collaboration and strong communication skills are essential. Some travel is required.

Requirements

• Master’s degree or other advanced degree in life sciences
• 10+ years working within the biotech/pharmaceutical industry
• 5+ years of Regulatory Ad/Promo experience
• Experience managing commercial regulatory strategy and labeling function
• Significant experience contributing to the development of commercial regulatory or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products
• Ability to lead matrixed teams, drive and influence effective collaborations
• Strong scientific writing and oral communication skills with ability to summarize clearly and succinctly and tailor messaging to target audience
• Initiative-taking, self-disciplined, and able to function independently as well as part of a team
• Proficient in various computer applications such as MS Project, Office suite, Smartsheet, etc

Responsibilities

• Define commercial regulatory strategies, ensuring all corporate communications comply with regulatory standards
• Provide regulatory guidance on new marketing concepts, messaging, and campaigns
• Review and approve all US promotional materials, working with cross-functional teams to ensure compliance with regulatory requirements and alignment with U.S. promotional regulations, corporate standards and policies, and business objectives
• Manage the strategy and operational aspects of regulatory labeling for Phase 3 and commercial assets, ensuring all labeling is accurate, compliant, and effectively communicates necessary information to healthcare professionals and patients
• Serve as the liaison and manage correspondence with FDA’s promotional review divisions and provide input on application labeling negotiations
• Lead the strategy, coordination, and execution of post-approval regulatory submissions (e.g., phase 3b/4 studies, amendments, aggregate annual reporting etc.), ensuring all submissions are timely and meet the expectations of regulatory agencies
• Maintain a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products
• Lead the development of Regulatory Affairs SOPs relevant to commercial procedures
• Represent RA Commercial at Regulatory team meetings as well as to stakeholders and cross-functional team members

Preferred Qualifications

• Prior regulatory filing (BLA/MAA) experience with cell or gene therapies
• Experience working directly with regulatory agencies in regulatory submissions and negotiations