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Otsuka Pharmaceutical Companies (U.S.) · 2 days ago

Associate Director, Regulatory Intelligence

United States

Full-time

Remote

Lead/Staff, Director/Executive

$165K/yr - $246K/yr

5+ years exp

Otsuka Pharmaceutical Companies (U.S.) is a leader in the pharmaceutical industry, and they are seeking an Associate Director of Regulatory Intelligence. The role involves leading the collection and dissemination of regulatory intelligence, overseeing the review of global regulatory news, and collaborating with subject matter experts to assess the impact of regulatory changes.

Health CareMedical

Comp. & Benefits

Responsibilities

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

Qualification

Regulatory AffairsRegulatory IntelligenceAI-enabled platformsMicrosoft OfficeProject ManagementInterpersonal SkillsCommunication SkillsCritical ThinkingTeam Leadership

Required

Minimum of 5 years of regulatory affairs experience

Minimum 2-3 years' work experience in regulatory intelligence

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

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)

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