Senior Director Regulatory Affairs

The Senior Director, Regulatory Affairs role sits at the intersection of science, compliance, and strategy. The position reflects an organization that operates in a pharma/biotech space, where regulatory leadership is a key driver of corporate success.

The scope of responsibility indicates that the company is active in global markets, requiring engagement with regulatory agencies such as FDA, EMA, ICH, and other authorities worldwide. This global orientation suggests the organization is managing a diverse pipeline with multi-jurisdictional considerations.

This position is not simply about regulatory execution; it is framed as a strategic leadership role with direct influence over corporate direction. The Senior Director is expected to provide thought leadership, shape long-term regulatory strategy, and guide the organization through complex approval pathways.

Reporting to the Vice President of Regulatory Affairs places the role within the senior leadership structure, signaling the importance of regulatory affairs as a strategic function aligned with business growth.

Key Responsibilities & Organizational Implications

1. Regulatory Strategy & Leadership

• Responsible for guiding regulatory approaches across the development lifecycle, from early-stage work through post-marketing.
• Serving as an advisor to executive leadership and cross-functional teams signals a need for strategic alignment across R&D, clinical, quality, manufacturing, and commercial groups.

2. Submissions & Approvals

• Oversight of high-quality regulatory filings (INDs, BLAs, NDAs, amendments, supplements, responses, etc.) reflects an active development pipeline and a company operating across multiple phases of product development.
• Involvement in due diligence for business opportunities implies that growth may also involve partnerships, licensing, or acquisitions.

3. Regulatory Compliance & Governance

• Close collaboration with Quality and Clinical teams shows that compliance is treated as an integrated organizational responsibility rather than a silo.
• The emphasis on monitoring regulatory change demonstrates the company’s commitment to staying ahead of evolving global requirements.

4. Leadership & Team Development

• Accountability for building and mentoring a high-performing team highlights the importance of leadership depth and succession planning.
• The call for fostering collaboration and accountability suggests a culture of operational discipline and continuous improvement.

Candidate Profile

The ideal candidate brings:

• An advanced degree in life sciences or a related field (PharmD, PhD, MS) and 12 years of progressive regulatory experience.
• A proven track record of successful regulatory submissions and approvals across multiple product types.
• Strong leadership, executive presence, and stakeholder management skills, reflecting the visibility and influence of the role.

Organizational Culture & Environment

• Integrity, adaptability, and resilience are emphasized, reflecting a fast-paced, dynamic environment where regulations and business priorities shift rapidly.
• The workplace is described as a professional corporate environment, consistent with an established organization with structured processes.
• Equal employment opportunity and inclusive practices point to a compliance-driven and people-focused culture.