Sr Specialist, Regulatory Affairs

Fujifilm - Holly Springs, NC

Full-time

Holly Springs, NC

Machinery Manufacturing

About the position

The Sr. Specialist, Regulatory Affairs at FDB plays a crucial role in ensuring compliance with FDA and EMA regulations while supporting the expansion of a new large-scale biopharmaceutical manufacturing facility. This position serves as a key liaison among various teams, guiding regulatory documentation processes and maintaining relationships with regulatory authorities. The role is integral to optimizing regulatory strategies and enhancing manufacturing flexibility with minimal impact on compliance.

Responsibilities

• Serves as the primary regulatory contact and liaison between commercial, operations, and expansion project teams.
• Leads and manages regulatory documentation processes, including the Site Master File (SMF), Drug Master File (DMF), and eCTD documentation.
• Supports and optimizes the regulatory aspects of tech transfer and new product introductions.
• Reviews and provides regulatory input on customer Statements of Work (SOW) and Quality Agreements (QUAG).
• Actively participates in industry groups to ensure FDB representation and involvement in working groups.
• Provides expert insights on FDA and EMA expectations to guide organizational decision-making.
• Manages cross-functional collaborative projects and leads team assignments.
• Plans and executes expansion meetings with regulatory authorities.
• Acts as the primary point of contact for the commercial team regarding new customers.
• Engages proactively with industry groups to influence future regulatory interpretations and standards.
• Participates in cross-site regulatory network and sustainability projects.

Requirements

• Bachelor's in Life Sciences or Engineering or equivalent with 8+ years of applicable industry experience OR a Master's in Life Sciences or Engineering and 6+ years of applicable experience OR a PhD in Life Sciences or Engineering and 4+ years of applicable experience.
• Prior experience and knowledge of FDA and EMA regulations, guidelines, and submission processes.
• Prior experience in developing and implementing regulatory strategies.
• Experience in managing regulatory documentation, including Site Master Files (SMF), Drug Master Files (DMF), and electronic Common Technical Documents (eCTD).

Nice-to-haves

• Previous experience with Quality System software and general IT savviness.
• Experience with complex projects to keep work pace and meet deadlines with good organization and planning skills.
• Experience in conducting regulatory risk assessments and developing mitigation strategies.
• Training and/or familiarity with Quality Risk Management principles.