Head of US Regulatory Affairs

Fresenius Kabi•Lake Zurich, IL

About The Position

The Head of Regulatory Affairs & Pharmacovigilance provide executive leadership and strategic direction for U.S. regulatory affairs and pharmacovigilance activities across the full product lifecycle (development through lifecycle) and is accountable for the development and execution of regulatory strategies and pharmacovigilance that ensure compliance with FDA requirements and enable timely product development, approval, commercialization, and lifecycle management. This position serves multiple business units across pharma and nutrition (both parenteral nutrition as well as food regulatory) as well as lifecycle support for biosimilars advertising and promotion, REMs and pharmacovigilance. The SVP mentors and provides regulatory guidance to team members including multiple levels of management and is accountable for driving operational excellence, fostering regulatory readiness, mentoring senior leaders, and ensuring compliance strategies support both U.S. and global business objectives.

Requirements

Bachelors degree in Pharmacy, Chemistry or Life Sciences
15+ years of relevant pharmaceutical experience, in drug regulatory, pharmacovigilance or food regulatory is required
at least 10 years of managerial experience.
Effective communication and leadership skills are essential.
Must be capable of making decisions, affecting a multitude of departments/disciplines to ensure that the company’s business/budgetary objectives are met with respect to product approval by the FDA.
The incumbent must be capable of interfacing with the Executive Group, Governmental Agencies and outside individuals on a regular basis.
Must have a complete understanding of the drug and food development and lifecycle process
Must be capable of handling extremely complex facts/data and developing decisions/recommendations quickly.

Nice To Haves

A strong business orientation is considered a plus.

Responsibilities

Define and execute U.S. regulatory strategies for A/NDAs, INDs, supplements, annual reports, and post-approval activities.
Review and approve regulatory submissions to ensure compliance with FDA laws, regulations, and sound scientific principles.
Lead and negotiate complex regulatory interactions with the FDA to achieve successful outcomes.
Monitor evolving regulatory requirements and global trends and translate them into effective internal processes and strategies.
Plan and implement regulatory activities including development, presentation, and review of required regulatory documents to support new products and addition in hospital formulary.
Ultimately responsible for the review and maintenance of regulatory documents and files (including product label, promotional materials and information packages); product history and registration activities for all products in the enteral Nutrition Business Unit.
Manage key regulatory programs, particularly those with unique regulatory strategies and position
Provide executive leadership for U.S. Regulatory Affairs and Pharmacovigilance, overseeing multiple regulatory disciplines and management levels.
Direct and align teams to ensure timely, high-quality submissions and efficient cross-functional workflows.
Translate corporate and business objectives into departmental goals and individual performance objectives.
Manage departmental budgets and resources in alignment with business and compliance objectives.
Lead by being an agent for change and questioning the status quo in an appropriate fashion.
Serve as Head of U.S. Vigilance, providing strategic oversight of FDA pharmacovigilance compliance.
May serve, upon nomination, as National Safety Officer (NSO) for the U.S. Market Unit.
Oversee adverse event reporting, signal management, literature reviews, periodic safety reports, and PV agreements with partners.
Ensure labeling, promotional materials, and marketing claims are compliant and scientifically supported.
Represent U.S. regulatory interests on global pharmacovigilance, labeling, and signal management committees.
Partners with teams to guide labeling changes, recall decisions, and resolution of safety and product quality issues.
Provide strategic leadership in literature reviews, clinical risk assessments, health hazard evaluations, and signal management activities.
Collaborate with R&D, Medical Affairs, Quality, Manufacturing, Commercial, Legal, and Government Affairs to support development and commercialization strategies.
Represent the company with regulatory agencies, professional organizations, business partners, and key opinion leaders.
Communicate regulatory and pharmacovigilance requirements and changes clearly across the organization.
Build, mentor, and retain a high-performing regulatory and vigilance organization.
Conduct performance reviews, address performance gaps proactively, and support leadership development.
Promote continuous learning, cross-training, and succession planning within Regulatory Affairs.
As a member of Top Management, hold overall accountability for Health, Safety, Environment, Energy, and Quality Management Systems.
Ensure policies and objectives are established, implemented, and aligned with the strategic direction of the organization.
Promote safe, healthy, and environmentally responsible workplaces.