Associate Director/ Director, Global Regulatory Lead

Role Summary

Associate Director/Director, Global Regulatory Lead – Global Regulatory Lead (GRL) to join the R&D organization, providing strategic directions to ensure successful product development and approval. Lead regulatory development strategies for multiple product candidates, shaping the regulatory framework and advancing gene and cellular therapies from development toward patient access.

Responsibilities

• Provide strategic vision and innovative scientific and regulatory leadership in defining a comprehensive science-based, solution-oriented global regulatory development strategy for assigned projects to achieve high quality and timely product registration and effective regulatory agencies interactions aligned with stakeholders needs.
• Proactively establish and maintain high-quality working relationships with regulatory agencies for assigned therapeutic areas and products. Monitor and assess impact of global regulations and the evolving regulatory, scientific and competitive environment.
• Represent Global Regulatory Affairs on assigned core product development teams and other relevant teams and/or governance bodies. Provide regulatory expertise and guidance to product development teams and other functions, applying appropriate competitive decision making.
• Provide regulatory direction in product development to align medical need with business objectives in the context of available and expected scientific data, and regulatory guidance and precedent.
• Lead the planning and implementation of global regulatory filings (IND/CTAs, BLAs).
• Oversee all submission activities and regulatory writing for regulatory documentation including meeting briefing packages, requests for special designations, INDs, BLA/MAAs and routine submissions.
• Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents).
• Present regulatory plans, risk assessments and strategies pertaining to the assigned project(s), including innovative strategic options which communicate the associated risks.

Qualifications

• A bachelor‚Äôs degree in pharmacy, biology, chemistry, pharmacology or related life science.
• Prior regulatory experience with a demonstrated track record of significant accomplishments:
  • Associate Director: 12+ Years with a bachelor's degree; 10+ Years with an advanced degree
  • Director: 15+ Years with a bachelor's degree; 12+ Years with an advanced degree
• Candidates must have thorough knowledge of pharmaceutical/biological product development and regulatory requirements across multiple regions (EU, US, New Zealand, Australia).
• Experience interfacing with regulatory agencies and ability to develop, communicate and implement global regulatory strategies.
• Strong written and verbal communication; ability to drive documents from start to finish with tight timelines and cross-functional teams.
• Strong analytical skills and ability to interpret and present complex data clearly.
• Independently motivated with good problem-solving ability.

Preferred Qualifications

• An advanced degree (MS/MBA, PhD or MD).
• Experience developing regulatory strategies and submissions from early development through marketing applications.
• Working knowledge of cellular and gene therapies or biologics development and manufacture, and relevant global regulatory environment.
• Knowledge of preparation of regulatory documents for INDs, CTAs, BLAs and annual reports; prior preclinical or clinical regulatory foundation.
• Experience in biologics development, clinical research, study design, biostatistics, regulatory environment, and medical terminology.
• Experience working in a small biotech environment.

Skills

• Collaborative ‚Äì Openness, One Team
• Undaunted ‚Äì Fearless, Can-do attitude
• Results Orientation ‚Äì Delivering progress toward mission with urgency
• Entrepreneurial Spirit ‚Äì Proactive ownership mindset