Job Description

The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to interpret the impact of regulatory changes to the pharmaceutical environment.

Job Description

• Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new and updated regulations and guidance that may impact pharmaceutical practices, procedures and controlled documents.
• Lead weekly regulatory intelligence team meetings to include review and discussion of ad hoc query requests, regulatory background package requests, health authority guidance, Federal Register notices, public commenting opportunities, and newsletter content.
• Manage development and distribution of weekly regulatory intelligence newsletters and regulatory watch notifications.
• Ensure regulatory intelligence specialists have continued access to regulatory, clinical trial, and public domain information resources to identify relevant regulatory-related news and information, and competitor product regulatory developments and report the most critical findings.
• Discuss and triage any technical issues with the reg intel platform, access requests, and distribution issues.
• Demonstrate comprehensive understanding of AI-enabled regulatory intelligence platform and dashboards to identify, tag, and summarize regulatory intelligence information.
• Monitor organizational strategic priorities and participate in cross-departmental discussions to consistently capture relevant and targeted regulatory intelligence.
• Regularly review and update AI taxonomy terms relevant to Otsuka approved and investigational products, clinical, and business development programs.
• Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and strengthen and support Otsuka as a learning organization.
• Maintain close communication with Informational Technology, Regulatory Technology, and the software vendor to maintain optimal functioning of the regulatory intelligence technology platform.
• Lead internal process to obtain, coordinate, and document cross-functional SME impact assessments of new or updated guidance and regulations.
• Lead regulatory public commenting process and posting of Otsuka comments to health authority websites.
• Review and update Regulatory Intelligence homepage on GRA Collaboration Portal.
• Manage onboarding and offboarding of regulatory intelligence team members, provide input on team member performance, establish annual budget, and manage spend.
• Author and conduct periodic review of regulatory intelligence management Standard Operating Procedures or work practices.
• Review overall quality of ad hoc query research for requested regulatory topics and confirm acceptability of responses.
• Demonstrate understanding of the major regional and global industry association priorities (e.g., PhRMA, EFPIA, JPMA, etc.).
• Demonstrate solid working knowledge of the drug, biologic, and device development process, laws, regulations, and guidelines from FDA, EMA, PMDA, ICH, etc.
• General knowledge of global regulations for pharmacovigilance reporting for approved and investigational products.
• Confirm list of upcoming regulatory meetings/workshops/conferences remains current.

Qualifications

• Master’s degree in a scientific or technical discipline preferred.
• Minimum of 5 years of regulatory affairs experience.
• Minimum 2-3 years’ work experience in regulatory intelligence.
• Previous interactions with FDA or other health authority are desirable.

Skills and Competencies:

• Demonstrates the ability to plan, direct, organize, and coordinate projects.
• Demonstrates experience interacting with and supporting senior leadership.
• Previous experience with people management and team leadership.
• Excellent interpersonal and communication skills, both written and verbal.
• Previous experience developing newsletters is desirable.
• Results driven and team-oriented collaborative approach required.
• Critical thinking and problem-solving skills.
• Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook).

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