Director, Regulatory Sciences

ProPharma seeks a Director, Regulatory Sciences to lead and oversee projects for US Regulatory science clients, manage a team of professionals, and ensure successful delivery of regulatory strategies, submissions, and other deliverables.

Requirements

• Develop and implement the overall strategy for regulatory submissions, approvals, and maintenance, aligned with the organization's goals and regulatory requirements.
• Lead and mentor a team of regulatory professionals, providing guidance, support, and training to ensure high performance and professional development.
• Stay updated on relevant regulations, guidelines, and industry trends, ensuring compliance and providing guidance to the team and stakeholders.
• Oversee the preparation, review, and timely submission of high-quality client deliverables, including managing interactions with regulatory authorities.
• Collaborate with cross-functional teams, including Research and Development, Manufacturing, Quality Assurance, and Legal, to ensure successful regulatory submissions within the defined timelines.
• Ensure robust quality oversight for regulatory submissions, ensuring adherence to regulatory requirements and best practices.
• Establish and maintain effective relationships with regulatory authorities, consultants, contract research organizations (CROs), and other external partners to support regulatory activities.
• Provide input as requested into the department's budget, optimizing resource allocation and ensuring cost-effectiveness.
• Identify and mitigate risks associated with deliverables and submissions, proactively addressing challenges and proposing solutions.
• Other duties as assigned.