Manager, Regulatory Compliance

Job Summary

• Provides critical support for regulatory compliance activities from planning to execution in alignment with the Global Regulatory Compliance Lead and working closely with cross-functional areas of the company.
• Provides strategic support for SOP maintenance and GxP compliance.
• Supports GRA inspection and audit readiness and management activities.
• Owns regulatory impact assessment compliance and tracking.

Job Description

• Function as SOP Coordinator supporting all GRA-related controlled document revisions cycles and ad-hoc revisions, work with the GSOP office to schedule KOM, manage timelines, follow up and support GRA key stakeholders with document revisions, maintain knowledge and access to GSOP systems (i.e., Veeva Vault, Monday.com), maintain the GRA SOP revision tracker, participate in quarterly GSOP engagement meetings, act as GRA representative for DEAL reviews
• Lead inspection readiness activities including but not limited to management of inspection calendar, supporting development of functional area slide presentations, scheduling KOMs, communicating audit/inspection notifications to the team, support pre-document requests, reviewing final audit reports, tracking CAPAs and Deviations
• Collaborate with Regulatory Intelligence and Pharmacovigilance to identify and confirm annual RRS updates
• Participates in review and qualification of PV dashboard curated inbox notifications
• Develop and implement the distribution of newsletters and compliance communications strategies to enhance organizational awareness and adherence to regulatory requirements
• Coordinate and facilitate monthly updates for regulatory milestone reports in partnership with Regulatory Strategy
• Support coordination and facilitation of GRA meetings such as the full staff meeting, SGRT, GRA departmental face-to-face meetings etc.
• Maintain updates to GRA Collaboration Portal, identify outdated materials, and manage quarterly update with key stakeholders to ensure accuracy of information posted
• Maintain updates to GRA contact list, Outlook GRA distribution lists, and departmental organizational charts
• Analyze compliance metrics and trends, provide recommendations along with monthly reports for key performance indicators such as training and post on the GRA Collaboration Portal to leadership, and drive corrective actions as needed
• Prepare and maintain compliance functional area work instructions such as SOP revisions, GRA milestone review, onboarding/offboarding materials
• Provide meeting support for cross functional meetings within GRA including development of project reports, presentation materials, meeting agenda, meeting minutes, identify outcomes and follow through on all deliverables.
• Ensure plans and activities are implemented in accordance with timelines and escalate any challenges or deviations for resolution in a timely manner
• Create, administer, and summarize surveys as needed

Qualifications/ Required

Knowledge/ Experience and Skills:

• Bachelor's degree in life sciences, scientific, or engineering field.
• 4+ years of general regulatory affairs experience and knowledge of the drug development process is required.
• 3 years audit and inspection experience.

Preferred Qualifications

• Prior experience working in the pharmaceutical and/or healthcare industry.
• Prior experience with new prescription drug/biologic applications (IND and/or NDA/BLA).
• Strong oral and written communication skills.
• Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc.
• Results-oriented, entrepreneurial and self-motivated with excellent organizational skills with ability to learn and grow
• Proactively manages and communicates issues, scopes, progress and risks throughout the project lifecycle ensuring key stakeholders are informed.
• Able to prioritize and work well in a fast-paced environment to multi-task, problem solve and support the Global Regulatory Leaders.
• Able to establish close communications and working relationship with cross-functional teams to meet business objectives.
• Strong demonstrated experience with Microsoft Office programs (Word, Excel, Powerpoint, Outlook) and familiar electronic document management systems (EDMS).
• Able to consider and offer innovative solutions to problem solving.

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

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Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting EEAccommodations@otsuka-us.com.

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About Us

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine.