Senior Principal, Regulatory Strategy

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 11%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Lumanity

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2020

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Lumanity is focused on improving the candidate experience through modern digital solutions. The company's initiatives include streamlining the application process and utilizing anonymous data to enhance user interaction on their platform. They emphasize privacy and compliance in their operations, ensuring that candidate data is handled with care and transparency.

📋 Description

• Deliver high-impact regulatory strategies for C-level and function-head client executives • Partner with the SVP & Practice Lead to execute Lumanity's Clinical & Regulatory practice strategy • Maintain direct accountability for client delivery, business development, and team growth and mentorship • Advise pharmaceutical and biotech C-suite executives and function heads on critical development, program-level, and portfolio-focused decisions • Provide regulatory guidance on complex development programs, including novel modalities • Collaborate with other Lumanity practices to deliver integrated solutions addressing approval and access challenges • Generate new business, meet individual sales targets, and secure business with net-new clients • Lead pursuit strategies for complex regulatory engagements and support practice business development • Develop multi-year account strategies for key relationships • Provide strategic oversight across engagements and proactively manage risk and delivery quality • Mentor Lumanity team members and carry direct reports as needed • Champion collaboration and knowledge sharing across markets • Represent Lumanity at industry forums and regulatory conferences • Monitor the regulatory competitive landscape and share insights • Translate regulatory landscape changes into practice growth opportunities • Develop regulatory points of view and thought leadership • Contribute to consulting methodologies and develop new service offerings

🎯 Requirements

• Minimum 15+ years progressive regulatory experience • Demonstrated success in both consulting environments and in-house biopharma regulatory roles • Direct experience leading regulatory strategies for development programs across multiple stages and therapeutic areas and/or product types • Demonstrated success contributing to or managing regulatory workstreams, projects, and teams • Proven ability to serve as a trusted advisor to pharmaceutical/biotech function heads and C-suite executives • Strong expertise across pre-IND through post-market/access regulatory activities, including designations, accelerated approval pathways, and complex regulatory strategies • Experience leading Pre-IND meetings, Type C meetings, EOP2 discussions, and other critical regulatory interactions • International regulatory experience across major markets (EMA, Health Canada, PMDA) with working knowledge of global regulatory harmonization • Deep regulatory expertise in 1+ major therapeutic area (oncology, CNS, rare disease, immunology, etc.) • Working knowledge and comfort working across other therapeutic areas • Experience across multiple product types, including small molecules, biologics, cell/gene therapies, and/or combination products • PhD, MPH, or MS in life sciences, regulatory affairs, or related field • Demonstrated ability to generate business and meet individual sales/revenue targets, with experience managing engagement-level budgets • Experience contributing to the development of new service offerings or capabilities within regulatory consulting • Active engagement in regulatory thought leadership, speaking engagements, and/or recognition as a subject-matter expert within one's professional network

🏖️ Benefits

• Competitive salary plus bonus scheme • Medical, dental, and vision insurance options • 401(k) plan with employer match • Flexible PTO • Flexible spending accounts for health and dependent care • Health savings account option with employer contribution • Employee Assistance Program • Paid short-term and long-term disability coverage • Professional development • Healthy work/life balance