Senior Director Regulatory Affairs (Raleigh)

Invenia Group has partnered with a fast-growing BioPharma company, looking to hire a Senior Director, Regulatory responsible for leading regulatory strategy, development, and execution across the companys biosimilar and generic product portfolios. This individual will serve as a senior leader and subject matter expert, guiding global regulatory submissions, interactions with health authorities, and ensuring compliance with applicable regulations. The role will lead the Regulatory team and requires strong leadership, strategic vision, and deep experience in both biosimilar and generic product development lifecycles.

Role responsibilities :

• Develop and lead regulatory strategies for biosimilar and generic products from early development through post-marketing.
• Serve as a senior regulatory advisor to executive leadership, R&D, clinical, manufacturing, quality, and commercial teams.
• Provide thought leadership on evolving regulatory frameworks for biosimilars and generics globally.
• Oversee preparation and submission of high-quality regulatory filings (e.g., INDs, ANDAs, BLAs, amendments, supplements, responses to information requests).
• Ensure timely approvals by proactively managing communications with FDA, EMA, and other global health authorities.
• Lead regulatory due diligence for business development opportunities.
• Ensure company-wide adherence to applicable regulations, guidelines, and internal SOPs.
• Partner with Quality and Clinical functions to resolve regulatory issues and support inspections and audits.
• Monitor and interpret regulatory changes, guiding internal teams on impact and implementation.
• Build, mentor, and lead a high-performing regulatory team supporting biosimilar and generic programs.
• Foster a culture of collaboration, accountability, and continuous improvement.
• Represent Regulatory Affairs to senior leadership and external industry associations.

What are we looking for?