At a recent San Francisco Bay Area RAPS chapter event, five distinguished industry experts shared their perspectives on strategic job searching and career growth in today’s rapidly evolving regulatory landscape. The panel featured our CEO Michelle Wu, Fabio De Martino (Founding Partner, Biolygon LLC), Peter Calcott (CEO, Calcott Consulting), Kiran Gulati (UCSC Extension Program Chair), and Surina Gulati (Sr. Quality Systems Engineer, Align Technology).
Essential Skills for Tomorrow’s Regulatory Professionals
Beyond Technical Knowledge
The panelists agreed that technical expertise alone isn’t enough. Fabio De Martino emphasized curiosity and the ability to navigate uncertainties, especially as regulatory agencies undergo changes. Peter Calcott stressed critical thinking: “You need to map out what is known and challenge the status quo, but don’t get emotionally tied to facts.”
Kiran Gulati highlighted business acumen and big-picture thinking, combined with strong communication skills and practical regulatory knowledge including risk management and quality systems.
The AI-Era Shift
Michelle Wu brought a technology perspective, explaining how AI is changing required skillsets: “In the era of AI, when you can fetch any factual answers through a search, the capability to ask high-quality questions is even more important.” This represents a fundamental shift from memorization-based learning to strategic questioning and critical thinking.
AI’s Impact on Regulatory Affairs
Current Automation Landscape
Michelle’s company has tracked AI adoption in regulatory affairs over five years. Research shows that approximately 700 occupations will be automated or augmented by AI, with regulatory roles seeing 15-21% of tasks becoming automated depending on seniority level.
AI as an Augmentation Tool
Peter Calcott emphasized that AI will handle “boring, laborious jobs” but won’t replace human judgment. He compared it to laboratory systems from 30 years ago: “It didn’t replace five FTEs – it changed the jobs those FTEs do.”
Strategic Job Searching with AI
The New Reality
Michelle Wu noted an interesting dynamic: “Now there’s AI helping candidates write their resume and AI tools screening resumes. So the first interview process is AI versus AI.” Understanding this reality is crucial for job seekers.
Practical AI Applications
Resume Optimization: Use AI to analyze your resume and provide specific feedback. Focus on specificity – detail how you completed project X, improved productivity by Y, and created impact Z.
Expanding Search: AI can identify relevant opportunities beyond traditional keyword searches, finding roles that match your skillset without obvious regulatory terms.
Interview Preparation: Use AI coaching tools to practice interview scenarios and build confidence.
Maintaining Authenticity
Despite AI capabilities, Surina Gulati emphasized authenticity: “Your resume should be so unique that if you dropped it on the floor, no one else could use it.” This is where networking and human connections become increasingly valuable.
Professional Development Strategies
Networking with Purpose
Michelle Wu stressed making “extremely specific asks” when networking rather than vague requests to chat. “Don’t be shy to ask – you’ll be surprised how willing people are to help in this collaborative community.”
She also recommended building independent expertise: “Give yourself one month to become the expert in a niche field. This becomes your ‘brain baby’ that makes you uniquely valuable.”
Excellence and Continuous Learning
Fabio De Martino emphasized doing your best work daily: “People move around and remember good colleagues. When opportunities arise, they’ll make that phone call.”
Kiran Gulati distinguished between upskilling (enhancing existing abilities) and reskilling (learning new capabilities), noting both are essential in today’s environment.
Building Organizational Impact
Culture Creation from Any Level
Peter Calcott explained that influence extends beyond job titles: “Your sphere of influence is defined by how you interact with people, whether it’s the CEO or peers or anyone in your organization.”
Michelle Wu emphasized leading with purpose: “Quality culture comes from the heart, not the head. Tell people not how or what to do, but why – what’s the mission for innovation, patients, and future generations.”
Practical Visibility Strategies
Surina Gulati shared her framework for manager meetings using four quadrants:
- Priorities: Current work focus
- Progress: Recent accomplishments
- Obstacles: Barriers needing support
- Growth: Development opportunities
She follows up with detailed meeting minutes, creating a record of contributions and commitments.
Strategic Risk-Taking
The panel encouraged taking stretch projects. Kiran Gulati advised being honest about knowledge gaps, while Fabio shared his mentor’s advice: “First say yes, then figure out what you want.”
Peter Calcott emphasized operating outside comfort zones: “99.9% of the time you get through stretch projects okay, and that’s where real learning happens.”
The Long-Term Relationship Advantage
Surina Gulati shared a powerful example: At a RAPS event eight years ago, she handed a speaker a water bottle as a volunteer. They stayed connected, and that person eventually hired her as a senior engineer at a Stanford AI startup.
Peter Calcott described similar results from 14 years of teaching at Genentech, where former students now in senior roles at other companies became consulting clients: “It’s doing the right thing, investing in the future, and it comes back to you.”
Key Takeaways
The regulatory field is rapidly evolving, but success still depends on fundamental principles:
- Combine technical expertise with soft skills – critical thinking, business acumen, and communication
- Embrace AI as a tool for augmentation while maintaining human judgment and authenticity
- Invest consistently in relationships through genuine networking and collaboration
- Take strategic risks with stretch projects and continuous learning
- Create a positive influence regardless of organizational level
- Stay curious and adaptable while focusing on the ultimate purpose: patient safety and product effectiveness
Professionals who balance technological adaptation with human connection, strategic thinking, and continuous growth will thrive in this evolving landscape. The key is embracing change while maintaining focus on the core mission of regulatory work: ensuring safe, effective products that improve lives.