The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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Quality/Risk Management, Regulatory Compliance, Submission & Registration, US Regulatory Affairs
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We have an immediate opening for an Associate Director, Regulatory Affairs (CMC/Biologics) at our US headquarters.
The Associate Director Regulatory Affairs (CMC/Biologics) will be proactive in helping to provide strategic CMC direction in the implementation of quality strategies, policies, procedures and optimal infrastructure to ensure systems are aligned with company submissions, LFB Corporate Quality, and applicable external regulatory authorities. This person/position will work closely with a number of LFB France groups providing guidance and expertise on CMC matters and will work closely with internal LFB Regulatory groups/personnel and provide input/writing/review of CMC sections of filings. This person/position may be asked to represent or participate in LFB for Regulatory Agency interactions (correspondence, conference calls, in-person agency meetings, etc.). At the Associate Director level, this person/position will demonstrate expertise in US and global regulatory principles, particularly for CMC issues, and specifically around biological products development and lifecycle management, for the benefit of collaborating with multi-functional, multi-disciplinary colleagues, partners, and stakeholders throughout the LFB organization.
The idea candidate will have the following experience:
BS + MS or applicable advanced degree in a relevant science (e.g. Chemistry, Biochemistry, Manufacturing or Physical Science) or equivalent CMC-focused industry experience (10-15 years) with clear practical understanding of Regulatory Affairs, Quality Assurance and GXPs as well as a strong Regulatory background with direct agency experience with an emphasis in CMC Biologics and product review matters. Experience in the regulatory sciences and considerations required for successfully shepherding biologic drug products to BLAs/MAAs approval stage (biological products and/or combination biologic products). Knowledge of all business disciplines to ensure ability to ‘partner’ with all functional departments of the organization. Demonstration of strategic planning, meeting objectives, technical and resource issue resolution. Strong leadership capabilities a must. Computer proficiency and familiarity with MS software applications. Excellent written and verbal communication skills. Ability to work and communicate with all levels within the organization. Must practice constructive engagement and have the confidence to challenge and be challenged to get the best strategies and solutions.
Telecommuting is allowed.
Additional Salary Information: competitive compensation and benefits package
Internal Number: R125
About LFB USA, Inc.
Today, LFB is among the leading European bio-pharmaceutical companies providing mainly hospital-based healthcare professionals with plasma-derived or recombinant medicinal products in three major therapeutic areas: immunology, haemostasis, and intensive care. Our US headquarters is based in Framingham, MA with facilities in Charlton, MA and Spencer, MA.
Life of patients is our purpose! Let's Work together in a climate of sharing, mutual exchange, trust and transparency.