FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive regulatory expertise across multiple therapeutic areas and product types, with a strong focus on strategic oversight and business development in the pharmaceutical and biotech sectors. Proven ability to mentor teams and deliver high-impact regulatory strategies while engaging with C-suite executives.
Highest-signal resume keywords
15+ Years Regulatory ExperienceRegulatory Strategy DevelopmentInternational Regulatory ExperienceBusiness Development ExpertisePhD, MPH, Or MS In Life Sciences
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory GuidancePre-IND MeetingsAccelerated Approval PathwaysComplex Regulatory StrategiesRegulatory Workstream ManagementTherapeutic Area ExpertiseProduct Type KnowledgeEngagement-Level Budget ManagementConsulting Methodologies DevelopmentThought Leadership Contributions
Soft Skills
MentorshipCollaborationTrusted AdvisorStrategic OversightKnowledge Sharing
Industry Keywords
PharmaceuticalBiotechRegulatory AffairsC-Suite EngagementClinical DevelopmentRegulatory Competitive LandscapeGlobal Regulatory HarmonizationOncologyCNSRare Disease
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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