Sr Director, Regulatory Affairs Strategy

About the Role The Senior Director Regulatory Affairs Strategy will play a key role in guiding assigned projects throughout development and lifecycle management by providing regulatory thought leadership and leveraging their extensive development experience. The individual will provide strategic as well as tactical regulatory leadership across all phases of product development, filing, and lifecycle management, to assure timely approval and compliant post-market performance in the US and key international markets. The individual should be able to proactively anticipate and mitigate regulatory risk, ensure compliance with global regulatory requirements and develop development acceleration strategies. In-depth understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices is required. The role will require strong leadership and interpersonal skills, both written and verbal. The candidate must have at least 15 years of regulatory affairs experience in the US and ex-US environments and a higher degree (MS, Ph.D. or PharmD) in a scientific discipline. Key responsibilities of the role: Serve as leader internally by collaborating across organizational levels and functions and effectively engaging stakeholders and influencing cross-functional decision-making to drive regulatory success. Oversee the development and execution of cutting-edge early-development through post-approval global regulatory strategies for complex assets and indications in partnership with other regulatory strategists and cross-functional stakeholders Provide regulatory leadership in global regulatory teams and product teams, including development regulatory strategy, planning, preparation and execution of major regulatory submissions (US and global), global submission rollout and lifecycle management strategies for marketed products including post-approval changes, ensuring continuous compliance Represent regulatory affairs in governance and in interactions with global health authorities, as applicable, to enable efficient pathways for development through lifecycle management Accountable for all US regulatory submissions and approvals for assigned projects. Able to identify and communicate regulatory hurdles, risks, opportunities, and innovative pathways to accelerate development and approval. Develop and lead regulatory intelligence gathering as well as regulatory influence management at the portfolio level. Provide strategic leadership and development to other regulatory strategists to ensure innovative, robust, fit-for-phase regulatory strategies for from FIH to approval. Provide regulatory strategy leadership for business development and due diligence, including assessment of asset, risk identification and mitigation, precedent leverage, regulatory probability of success Establish best practices across Regulatory Affairs and other R&D functions to ensure consistent, high-quality execution Follow company policies and procedures for regulatory record keeping and lead development of new regulatory policies and procedures. Advance the organization’s goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects. Factors for Success: The candidate must have at least 15 years of regulatory affairs experience and a higher degree (MS, Ph.D. or Pharm D.) in a scientific discipline. Excellent verbal and written communication skills. Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills evidenced by past performance on drug development project teams. Ability to function at a high level in a team setting or acting as an individual contributor. Ability to thrive in a fast-paced, entrepreneurial environment. An excellent understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices. A high attention to detail and ability to coordinate and prioritize assigned projects. Decision Making