Associate Director of Regulatory Affairs Insights

The Associate Director of Regulatory Affairs Insights will spearhead initiatives to collect and disseminate vital regulatory information. By collaborating closely with subject matter experts, you will assess how regulatory changes influence the pharmaceutical industry. Key Responsibilities: Lead the collection, analysis, and distribution of critical global regulatory updates, including changes that may impact pharmaceutical practices. Conduct weekly team meetings to review ongoing regulatory inquiries, update requests, health authority guidance, Federal Register notifications, and newsletter topics. Oversee the creation and distribution of weekly regulatory intelligence newsletters and alerts. Ensure the regulatory intelligence team has continuous access to essential resources for identifying relevant news and competitor regulatory updates. Resolve technical issues related to the regulatory intelligence platform, including access and distribution concerns. Leverage your comprehensive understanding of an AI-driven regulatory intelligence platform to effectively tag and summarize pertinent information. Align regulatory intelligence efforts with the organization's strategic priorities by participating in cross-departmental discussions. Regularly update AI taxonomy terms relevant to Otsuka's approved and investigational products, along with clinical and business development programs. Develop a strong network with key stakeholders to ascertain regulatory intelligence needs, enhancing Otsuka's reputation as a learning organization. Maintain open communication with IT, Regulatory Technology, and software vendor teams to ensure the smooth operation of regulatory intelligence technology. Coordinate the internal process for collecting and documenting cross-functional assessments regarding new or revised guidance and regulations. Lead the submission process for regulatory public commentary, including Otsuka's feedback to health authority platforms. Enhance the Regulatory Intelligence homepage on the GRA Collaboration Portal. Manage the onboarding and offboarding processes for regulatory intelligence team members and participate in performance evaluations, budget development, and financial management. Author and review regulatory intelligence management standard operating procedures (SOPs) and work practices. Ensure the quality of ad hoc research on regulatory topics to guarantee the accuracy of responses. Demonstrate a solid understanding of the priorities of major regional and global industry associations. Maintain in-depth knowledge of the drug, biologic, and device development processes, including relevant laws and guidelines. Stay updated on global pharmacovigilance reporting requirements for both approved and investigational products. Ensure an up-to-date list of upcoming regulatory meetings, workshops, and conferences. Qualifications: A Master's degree in a scientific or technical field is preferred. A minimum of 5 years of regulatory affairs experience is required. 2-3 years of experience in regulatory intelligence is essential. Prior interactions with FDA or other health authorities are advantageous. Skills and Competencies: Proven ability to effectively plan, direct, and coordinate projects. Experience supporting and interacting with senior leadership. Experience in people management and team leadership is beneficial. Strong interpersonal and communication skills, both verbal and written. Experience in newsletter development is a plus. Results-oriented with a collaborative, team-focused approach. Strong critical thinking and problem-solving abilities. Proficient in Microsoft Office applications. Core Competencies: Accountability for Results: Maintain focus on strategic objectives and uphold high-performance standards. Strategic Thinking: Make impactful decisions considering long-term effects on stakeholders and the business. Customer Focus: Prioritize the needs of customers and key stakeholders. Effective Communication: Clearly convey messages with influence across all organizational levels. Team Collaboration: Value diverse perspectives and work collaboratively towards common goals. Professional Development: Engage actively in personal and professional growth as a business priority. Salary range: Minimum $164,530.00 - Maximum $245,985.00, plus additional incentive opportunities based on experience and skills. This is for positions based in the United States. Company Benefits: Enjoy comprehensive medical, dental, and vision coverage, basic life insurance, short- and long-term disability insurance, tuition reimbursement, and a generous 401(k) matching program, along with flexible time off and paid leave programs. Join us at Otsuka for a fulfilling career in regulatory intelligence!

Created: 2026-03-04