We are 'Advancing tomorrow's medicines' and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow's medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.
The Regulatory Affairs Manager is responsible for providing regulatory expertise to the site and, as directed, to other FDB sites. Performs regulatory surveillance, interpreting regulatory documents into site-specific and into multi-site documentation, ensures site master files are maintained and published, and collaborates with Clients on regulatory responses and commitments pre- and post-PAI. The individual is a subject matter expert with regard to QA and regulatory practices and procedures and provides leadership to others while providing regulatory direction throughout the organization. This position reports to Associate Director, QA and will have additional matrix reporting responsibilities and accountabilities.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
Performs regulatory surveillance, interpreting agency documents into site-specific documents, ensuring compliance across multi-site documentation, such as policies and master plans. Primary site resource for regulatory issues on strategic programs and FDB harmonization. (30%)
Manages the regulatory activities for multiple projects, collaborates with Clients on regulatory responses and tracks regulatory commitments to closure. (30%)
Evaluate, schedule and balance workload and responsibilities (20%)
Review/approval/publication of site master files
Ensures site regulatory licenses and master files are maintained
Primary site resource for regulatory issues, providing learning opportunities
Supports FDBT in registration
Identify improvements and implement
Prepares and delivers presentations to internal and external customers
Provide cross-functional regulatory leadership as recognized authority on compliance and regulatory issues and assists less experienced peers. Represents Quality management for internal and external duties when requested. (15%)
Other duties as assigned (5%)
This position is the site regulatory expertise utilized by various functions to ensure the site activities are in alignment with regulatory requirements. The manager will use their influence and tact to achieve regulatory requirements are achieved with a wide latitude for independent judgment. This position applies advanced regulatory knowledge and experiences to implement strategies, initiatives and actions to ensure and improve regulatory compliance.
May demonstrate supervisory skills, directly or indirectly, within a staff of 1-2 technical professionals (outside contractors and consultants) and has financial approval authority as defined in the company's authorization matrix. Establishes standards and approves site-level policy documentation by partnering across company functions to collaborate effectively as a resource to other colleagues.
Minimum of BS degree in science or related field.
Minimum of 10 years of GMP and regulatory experience in pharmaceutical industry.
Extensive knowledge of GMPs with the ability to interpret and apply to non-routine situations.
Deep understanding and command of regulatory requirements.
Also requires a demonstrated record of accomplishment in the following key areas:
Ability to interpret regulations and apply to non-routine situations
Strong orientation for quality, compliance, business ethics and customer service
High level of integrity, personal discipline and personal responsibility.
Exhibit strong collaboration, flexibility and able to manage multiple changing priorities
A strategic thinker, able to motivate, lead and develop subordinates and the site leadership
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 - 130 and Export Administration Regulations in 15 C.F.R. Part 730 - 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.