Director, Regulatory Affairs Strategy

Role Summary

Director of Regulatory Affairs Strategy will guide new products into the clinic and set the stage for registration. They will serve as Regulatory Lead for pipeline drug development programs and marketed products, responsible for developing, implementing, and driving global regulatory strategies. The role requires a strong scientific background and broad drug development experience to impact program teams beyond regulatory strategy. This position reports to the Executive Director, Regulatory Strategy.

Responsibilities

• Serve as Regulatory Lead, representing the Global Regulatory Team on cross-functional development teams
• Develop and implement global regulatory strategies for pipeline drug development programs and marketed products
• Identify innovative, data-driven regulatory approaches, define plans to proactively mitigate risks, and monitor the competitive and policy landscape for changes with potential impact
• Lead the organization and preparation of clear and effective regulatory submissions that align with company strategies and Health Authority requirements
• Foster strong relationships with relevant regulatory agencies and key stakeholders while advocating for company positions
• Lead interactions with Health Authorities, interpret feedback, and ensure that the outcome is properly communicated to the Organization
• Create a strong regulatory community and share best practices across the broader Regulatory Affairs organization
• Effectively represent the Regulatory Affairs function to senior leadership at governance meetings

Qualifications

• Required: Degree in life sciences; advanced degree preferred
• Required: At least 10 years’ experience in the biopharma industry in a Regulatory Lead role
• Preferred: Proven ability to represent Regulatory on project teams and at Health Authority meetings
• Preferred: Demonstrated strategic thinking skills, sound judgement, and ability to integrate strategies into actionable plans
• Preferred: Strong knowledge of global regulatory principles and practices across the drug development lifecycle, ideally with an emphasis on neurology drugs
• Preferred: A thorough understanding of the drug development process and working knowledge of the essential activities for all key functional areas
• Preferred: Excellent oral and written communication skills; solid grasp of effective regulatory writing fundamentals and ability to communicate complex issues clearly and concisely
• Preferred: Strong team player: the ability to work flexibly in a collaborative environment and assist team members as needed to achieve goals
• Preferred: Capable of project managing regulatory workstreams, identifying the critical path for submissions, and partnering with functional leads to manage timeline risk
• Preferred: Able to work independently on competing priorities in a fast-paced and dynamic environment; a creative thinker with good attention to detail