Head of Regulatory Operations

March 26

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Red Nucleus

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Red Nucleus is a company specializing in healthcare and life sciences services, offering a wide range of advisory and scientific services. With over three decades of experience, they provide solutions across the life sciences product life cycle, aiming to improve health outcomes. Their services include market access and commercialization, medical communications, and learning and development. Red Nucleus also offers products like DirectusPRO and iTakeControl. They focus on supporting strategic and operational challenges in healthcare through their expertise in areas like Quality, Clinical, Safety, Regulatory, and Medical Affairs. The company employs a team of over 700 members dedicated to advancing knowledge and improving lives.

market access • regulatory operations • advisory • clinical research • commercialization

501 - 1000 employees

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Red Nucleus is hiring a Head of Regulatory Operations to lead a global team. • The Head of Regulatory Operations will manage their own team while ensuring client regulatory filing needs are met. • This role is accountable for RegOps sales and revenue targets between $7M-$10M annually. • You will independently manage sales pitches and client negotiations while maintaining RegOps specific marketing content. • The role requires strategic oversight and management of global project delivery and client relationships.

🎯 Requirements

• Bachelor’s degree (minimum requirement) • 15-20 years of experience in the pharmaceutical industry with a focus in Global Regulatory Operations • 15-20 years of experience publishing, submitting and managing global documents and submissions in a document repository • Experience driving strategy for Global Regulatory teams • Experience managing and forecasting departmental budgets, including but not limited to, revenue, P&L, sales, gross margins • Experience in project managing major (NDA, MAA, etc.) submissions • Understanding of global drug development documents • At least 15 years of experience with global publishing • At least 15 years of experience with regulatory global registration management information and systems • Experience with the implementation of a regulatory technology such as, Veeva, Documentum, First Docs, etc. • Experience in the migration of documents and submissions from one regulatory system technology to another • Proficient in Microsoft Suite software including Excel, Word, Powerpoint, Visio • Proficient with industry standard RIM/submission management software • Ability to travel up to 50%

🏖️ Benefits

• Competitive pay, incentives, retirement, and income security programs • Comprehensive benefits and wellness programs focused on healthy lifestyles • Generous paid time off, employee assistance programs and flexible work arrangements • Performance-driven environment including professional development and transfer opportunities • People-first culture fostering self-expression, diversity, and a growth mindset • Celebrations! We love to celebrate service anniversaries, holidays, diversity and inclusion events, project milestones and anything else that is meaningful to our employees • Support of the community organizations you are passionate about • Ongoing programs and events designed to bring our global team together