Associate Director of Regulatory Insights

The Associate Director of Regulatory Insights will lead efforts in collecting and sharing critical regulatory information while working closely with subject matter experts to assess how regulatory changes impact the pharmaceutical sector. Key Responsibilities: Oversee the gathering, analysis, and sharing of essential global regulatory updates, including new regulations and guidance that could affect pharmaceutical practices. Facilitate weekly team meetings to discuss ongoing regulatory inquiries, update requests, health authority guidance, Federal Register notifications, and newsletter topics. Manage the creation and distribution of weekly regulatory intelligence newsletters and alerts. Ensure the regulatory intelligence team has continual access to vital resources for identifying relevant news and critical competitor regulatory updates. Address technical issues related to the regulatory intelligence platform, including access and distribution matters. Utilize a comprehensive understanding of an AI-driven regulatory intelligence platform to effectively tag and summarize relevant information. Align regulatory intelligence gathering with organizational strategic priorities by participating in cross-department discussions. Regularly update AI taxonomy terms pertinent to Otsuka's approved and investigational products, as well as clinical and business development programs. Build a network with key stakeholders to identify regulatory intelligence needs, enhancing Otsuka's reputation as a learning organization. Maintain communication with the IT, Regulatory Technology, and software vendor teams to ensure optimal operation of the regulatory intelligence technology. Coordinate the internal process for gathering and documenting cross-functional assessments regarding new or revised guidance and regulations. Lead the process for regulatory public commentary, including the submission of Otsuka's comments to health authority platforms. Enhance the Regulatory Intelligence homepage on the GRA Collaboration Portal. Oversee the onboarding and offboarding processes for the regulatory intelligence team members and contribute to performance evaluations, budget establishment, and financial management. Author and review regulatory intelligence management standard operating procedures (SOPs) or work practices. Review the quality of ad hoc research on regulatory topics to ensure response accuracy. Demonstrate a strong understanding of the priorities of major regional and global industry associations. Possess in-depth knowledge of the drug, biologic, and device development processes, including relevant laws and guidelines. Maintain knowledge of global pharmacovigilance reporting requirements for both approved and investigational products. Ensure the list of upcoming regulatory meetings, workshops, and conferences is up-to-date. 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 beneficial. Skills and Competencies: Proven ability to plan, direct, and coordinate projects effectively. Experience in supporting and interacting with senior leadership. People management and team leadership experience is advantageous. 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 decisions considering long-term impacts on stakeholders and the business. Customer Focus: Keep the needs of customers and key stakeholders as a priority. Effective Communication: Convey messages with clarity and influence at all organizational levels. Team Collaboration: Value diverse perspectives and collaborate towards common goals. Professional Development: Engage in active development 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 generous 401(k) matching, along with flexible time off and paid leave programs. Join us at Otsuka for a rewarding career in regulatory intelligence!

Created: 2026-03-10