Associate Director/ Director, Global Regulatory Lead

Role Summary

Associate Director/ Director, Global Regulatory Lead. Lead global regulatory strategy and execution for assigned product development programs, shaping regulatory interactions and submission plans to enable timely product registrations and approvals.

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.
• Pro-actively establish and maintain high-quality working relationships with regulatory agencies as appropriate for assigned therapeutic areas and products. Monitor and assess impact of relevant 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, including external alliances and partnerships. Provide regulatory expertise and guidance to product development teams and other functions of the company as needed, including by 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 but not limited to 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

• 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 bachelor‚Äôs degree; 10+ years with advanced degree.
• Director: 15+ years with bachelor‚Äôs degree; 12+ years with advanced degree.
• Candidates must have thorough knowledge of pharmaceutical and/or biological product development and regulatory requirements in more than one key region (e.g., EU, US, New Zealand, Australia).
• Experience interfacing with regulatory agencies and proven skill at developing, communicating and implementing successful global regulatory strategies.
• Demonstrated ability to communicate and write clearly, concisely, and effectively.
• Experience driving documents through from start to finish with tight timelines and cross-functional study teams.
• Strong analytical skills and ability to interpret and present complex data clearly.
• Independently motivated with good problem-solving ability.

Skills

• Regulatory strategy development
• Global regulatory submissions (IND/CTAs, BLAs)
• Regulatory writing and documentation
• Cross-functional collaboration
• Analytical data interpretation

Education

• Advanced degree (preferred but not required): MS/MBA, PhD or MD

Additional Requirements

• Working knowledge of cellular and gene therapies or biologics development and manufacture, and the relevant global regulatory environment.
• Experience in a small biotech environment (preferred).
• Travel/onsite expectations: role refers to in-person collaboration; on-site presence required for a portion of the week as part of a dynamic, collaborative work environment.