How to Interview a Regulatory Affairs Director

Hiring senior regulatory affairs talent in life sciences is a leadership decision with direct impact on regulatory outcomes, development timelines, and organisational risk. At director level, these critical roles shape regulatory strategy, regulator relationships, and how the business responds under scrutiny. 

Effective interviews must focus on judgment, influence, and decision making in complex regulatory environments. This guide outlines how to interview a Regulatory Affairs Director using a structured, role-relevant assessment that supports confident hiring decisions. 

What to assess when interviewing a Regulatory Affairs Director in life sciences 

A Regulatory Affairs Director operates at the enterprise level. Interviews should assess how a candidate thinks, leads, and takes accountability for regulatory outcomes across functions and regions. 

Focus on the candidate’s ability to: 

• Own regulatory strategy across the full product lifecycle, from early development through post-approval change 
• Balance regulatory compliance with development timelines, commercial pressure, and resource constraints 
• Represent the organisation credibly with health authorities, including escalation and issue resolution 
• Influence senior stakeholders across clinical, quality, manufacturing, supply chain, and commercial teams 

Strong candidates articulate decisions they have made, risks they have accepted or mitigated, and outcomes they have owned. Vague descriptions or over-reliance on team effort often indicate limited accountability. 

Core competencies required for Regulatory Affairs Directors in pharma, biotech, and medical devices 

Director-level regulatory affairs talent should demonstrate capability across a defined set of leadership and strategic competencies. 

These include: 

• Regulatory strategy and planning, including long-term pathway design, jurisdictional sequencing, and contingency planning 
• Regulator engagement, covering meeting strategy, written interactions, negotiation, and issue management 
• Risk management, including escalation thresholds, documentation standards, and defensible decision making 
• Leadership and team development, with evidence of building resilient teams and succession capability 
• Cross-functional influence, aligning regulatory objectives with development, quality, and commercial priorities 

Interviews should test these competencies directly, rather than assuming seniority equates to capability. 

Regulatory Affairs Director interview questions to test strategic leadership 

Strategic regulatory leaders distinguish themselves through how they think through uncertainty and trade-offs. 

Effective questions explore: 

• How regulatory strategy was shaped when data, guidance, or timelines were unclear 
• Situations where regulatory advice conflicted with internal expectations or investor pressure 
• Decisions that required influencing executives to change direction or delay milestones 

Ask candidates to explain the context, the options considered, the risks accepted, and the rationale behind their final decision. Look for structured thinking, clarity of communication, and evidence of accountability. 

How to assess global regulator engagement experience, including FDA, EMA, and MHRA 

Regulatory Affairs Directors play a visible and accountable role in external engagement. Their approach to regulators directly affects credibility, outcomes, and internal confidence. 

Assess candidates on: 

• How they prepare organisations for formal regulatory interactions, including internal alignment and briefing discipline 
• How they define meeting objectives and manage expectations before, during, and after agency engagement 
• How they respond to unexpected or challenging feedback and translate it into actionable internal plans 

Strong candidates describe regulator engagement as a managed process, not a single event. They focus on preparation, clarity, documentation, and follow-through. 

Scenario-based interview questions that reveal real-world decision making 

Scenario-based assessment provides insight into how candidates operate under pressure and ambiguity. 

Use scenarios such as: 

• A late-stage issue identified shortly before a planned submission 
• Conflicting feedback received from different regulatory authorities 
• Delays or additional requirements introduced through regulatory change or evolving guidance 

Ask the candidate to walk through their response step by step, including stakeholder management, risk assessment, documentation, and decision ownership. This reveals how they balance speed, compliance, and accountability in practice. 

Red flags to watch for when hiring Regulatory Affairs Directors in life sciences 

Certain behaviours consistently indicate risk at the director level. 

Watch for candidates who: 

• Frame success around submission completion rather than regulatory outcomes 
• Avoid ownership of decisions or deflect accountability 
• Struggle to explain regulatory trade-offs 
• Over-index on technical detail without linking it to strategy or business impact 

At the senior level, clarity of judgement, decision ownership, and influence matter more than technical recall. 

How to structure interviews for consistent, defensible hiring decisions 

Structured interviews improve consistency and reduce hiring risk for senior regulatory roles. 

Best practice includes: 

• Clear competency criteria aligned to the scope and maturity of the role 
• Defined interview responsibilities across the panel to avoid duplication 
• Follow-up questions that test depth, rationale, and accountability 

This approach supports better comparison between candidates and leads to stronger long-term hiring outcomes. 

Hiring senior regulatory affairs talent in life sciences? 

Hiring a Regulatory Affairs Director directly affects regulatory credibility, development timelines, and organisational confidence. Working with a specialist life sciences partner gives access to experienced regulatory affairs talent, market insight, and role-specific assessment expertise. 

EPM Scientific supports organisations hiring senior regulatory leaders across pharma, biotech, and medical devices, with a focus on quality, discretion, and long-term fit. We also partner across related compliance functions, including quality, validation, pharmacovigilance, and drug safety, supporting integrated hiring strategies across regulated environments. 

Request a call back to discuss your regulatory hiring plans, role scope, and market conditions, or submit a vacancy to access specialist regulatory affairs talent, targeted search, and informed shortlisting aligned to your organisation's needs. 

Senior regulatory professionals can click here to browse current vacancies across life sciences compliance functions.