Director, Regulatory Affairs

Position Overview

The Director Regulatory Affairs is a pivotal role providing regulatory expertise and leadership to the FUJIFILM Biotechnologies North Carolina sites and globally as needed. This role serves as the subject matter expert (SME) for regulatory practices and procedures offering strategic direction throughout the organization. Additionally the Director leads a team of regulatory specialists through fostering a culture of growth and development in alignment to organizational goals while collaborating cross-functionally to drive continuous improvement and optimize Regulatory approaches.

Company Overview

At FUJIFILM Biotechnologies were leading the charge in advancing tomorrows medicines. If you want to be a part of life-impacting projects alongside todays most innovative biopharmaceutical companies FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site we thrive on collaboration creativity and purpose. Whether your expertise lies in research manufacturing or production youll find a home here where your efforts directly improve patients lives. Together lets shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP) North Carolina our site is at the heart of a booming biotech hub surrounded by top universities vibrant communities and various outdoor opportunities.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit : Description

What Youll Do

• Leads mentors and sets the objectives for the Regulatory Affairs team across the North Carolina sites
• Performs regulatory surveillance and ensures effective implementation within the organization
• Serves as the SME and primary contact for regulatory inspections and audits and strategic programs and harmonization across the organization
• Oversees and coordinates regulatory activities for multiple projects ensuring compliance throughout the project lifecycle
• Collaborates with clients on regulatory responses and tracks commitments for timely closure
• Develops and conducts training sessions to enhance regulatory knowledge to ensure adherence to best practices
• Participates in sustainability projects with a transformative and responsible approach
• Engages in industry groups and publishes regulatory successes to drive industry transformation
• Participates in site Quality Leadership Teams (QLTs) and coordinate regulatory assignments
• Navigates regulatory complexities and differences across microbial mammalian commercial clinical drug substance and primary and secondary packaging at the North Carolina sites
• Ensures alignment with Regulatory leaders globally for best practices and consistent and transformative approaches
• Partners cross-functionally to identify areas for improvement develop action plans and collaborate to implement improvement initiatives
• Manages regulatory activities such as Site Master File 3.2.A.1 Drug Master Files and customer filing
• Administers company policies and completes required tasks (e.g. time off approvals expense reports etc.)
• Encourages a culture that prioritizes continuous learning and development including coaching and real-time feedback to ensure the team is positioned for growth
• Partners with HR Talent Acquisition and various stakeholders to recruit talent and create retention strategies as needed
• Evaluates team performance addresses gaps and implements measures to improve productivity and engagement and develops high-potential employees
• Performs other duties as assigned

Knowledge and Skills

Basic Requirement

Preferred Requirements

Working Conditions & Physical Requirements

To all agencies : Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms / employment agencies to any employee at FUJIFILM via-email the internet or in any form and / or method will be deemed the sole property of FUJIFILM unless such search firms / employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Required Experience :

Director

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Unclear

Department / Functional Area : Regulatory Compliance

Experience : years

Vacancy : 1