Director, Regulatory Affairs

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: 5 days ago

Vacancies: 1 Vacancy

Department:

Regulatory Compliance

Job Summary

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

Knowledge of Good Manufacturing Practices (GMP) and other related regulations
Ability to interpret regulations and apply to non-routine situations
Deep understanding of regulatory intelligence US EMEA and ROW regulations and the accreditation of Foreign Manufacturers (FMA) in Japan
Willingness to engage and align to KojoX and One FUJIFILM Biotechnologies initiatives
Ability to adapt communications style to differing audiences advise on difficult matters and navigate crucial conversations
Strong orientation for quality compliance business ethics and customer service
High level of integrity personal discipline and responsibility
Exhibits strong collaboration flexibility and ability to manage multiple changing priorities
Strong strategic thinking and project management skills
Ability to effectively present complex information to others
Demonstrated ability to hire and develop technical talent to lead a high performing team projects and programs
Willingness to participate within industry groups and conferences
Must be flexible to support 24/7 manufacturing facilities and collaborate with global colleagues

Basic Requirement

Masters degree in life science or engineering field with 11 years of regulatory experience in a pharmaceutical or manufacturing environment; or
Bachelors degree in life science or engineering field with 13 years of regulatory experience in a pharmaceutical or manufacturing environment
10 years of people management leadership & team management experience

Preferred Requirements

Regulatory and GMP experience in the pharmaceutical industry

Working Conditions & Physical Requirements

Ability to stand for prolonged periods of time up to 30 minutes.
Ability to sit for prolonged periods of time up to 30 minutes.
Ability to conduct activities using repetitive motions that include wrists hands and/or fingers.

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.

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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

Position OverviewThe 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...