Associate Director - Regulatory Affairs, Labeling, Advertising and Promotion

February 13

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Orca

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Orca is a platform that facilitates trading and liquidity provision by leveraging the speed of Solana blockchain technology on the Ethereum network. It allows users to trade, manage portfolios, and connect their wallets on the Eclipse network. Designed to provide a seamless experience by combining Ethereum's ecosystem with Solana's rapid processing capabilities, Orca targets users interested in cryptocurrency trading and liquidity solutions.

11 - 50 employees

💳 Fintech

₿ Crypto

💸 Finance

📋 Description

• More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. • With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. • Reporting to the Head of Regulatory Affairs, the Associate Director is responsible for the development and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent with regulatory guidelines, our company's policies, and support business objectives. • The individual is also responsible for leading and/or contributing to the planning, coordination, and execution of other post approval regulatory submissions. • The successful candidate will interface cross-functionally in a matrixed environment to integrate commercial Regulatory plans and ensure planning, coordination, and communication to develop timely and robust regulatory strategies and submissions to meet overall program objectives/milestones. • Some travel required, as needed.

🎯 Requirements

• Master’s degree or other advanced degree in life sciences, 10+ years working within the biotech/pharmaceutical industry, and 5+ years of Regulatory Ad/Promo experience required • Prior regulatory filing (BLA/MAA) experience with cell or gene therapies preferred • Experience managing commercial regulatory strategy and labeling function required • 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. • Experience working directly with regulatory agencies in regulatory submissions and negotiations is a plus • 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.