Senior Manager, Regulatory Affairs

Job Summary

• Provides critical support in the GRA project coordination of activities from planning to execution in alignment with the Global Regulatory Head and working closely with cross-functional areas of the company.
• Sr. Manager Regulatory Affairs is the Global Project Coordination & Compliance functional unit lead in GRA.
• Drives project coordination activities for GRA related activities and drive continuous improvement and innovation opportunities.
• Provides strategic support for regulatory document management and GxP compliance.
• Provides leadership for the preparation, review, implementation, and maintenance of regulatory controlled procedural documents. This includes ensuring development of appropriate training and monitoring training compliance in GRA.

Job Description

• Sets the strategic direction and provides leadership for the Global Project Coordination & Compliance function.
• Leads teams to ensure effective coordination, collaboration, and outcomes on GRA activities and projects.
• Leads audit and inspection readiness activities to prepare teams for audits/inspections but also to drive an inspection ready mindset.
• Manage and coordinate activities related to active Regulatory related audits and inspections.
• Implement and train GRA organization on inspection readiness processes, tools, and templates. ​
• Coordinate and facilitate projects, teams and meetings across the globe​.
• Develop agendas, communicate meeting outcomes and track actions until completion​.
• Ensure plans are implemented in accordance with timelines and any issues, challenges or deviations are escalated for resolution in a timely manner​.
• Works closely with regulatory colleagues across sites, countries and areas to ensure consistent approaches are employed where possible.
• Provides leadership for the consolidation of key measures into a reportable presentation to senior management or others as needed.
• Implement and train organization on new streamlined tools, templates and processes. ​
• Program manage and oversee meeting coordination of Senior Global Regulatory Affairs Team (SGRT)
• Preparation of regulatory portfolio and management presentations
• Conduct regular review of roles and training curriculas​
• Oversee coordination of GRA budget management activities

Qualifications/ Required

Knowledge/ Experience and Skills:

- Bachelor's degree in life sciences, scientific, or engineering field.

- 3+ years of project management experience and knowledge of the drug development process is required. Knowledge or background in Regulatory Affairs is preferred.

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).

- 2+ years of experience managing internal staff and/or external consultants.

- PMP certification. Knowledge, Skills and Other experience

- 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 problem solving innovative solutions. Come discover more about Otsuka and our benefit offerings; click here for more information 

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