Job Description:

RESPONSIBILITIES:

Kforce's client in Deerfield, IL is seeking a Project Manager.

Overview:
We are seeking a highly skilled and motivated Regulatory Affairs Project Manager to join our team. This role will be pivotal in supporting the successful spin-off of one of our divisions. The Regulatory Affairs Project Manager will work closely with various divisions, including supply chain, labeling, and manufacturing, to ensure compliance with regulatory requirements and facilitate a smooth transition.

Key Responsibilities:

• Lead and manage regulatory projects related to the spin-off, ensuring timelines and deliverables are met


• Ensure all activities comply with relevant regulatory requirements, including FDA, EMA, and other global regulations


• Work closely with supply chain, labeling, and manufacturing teams to support regulatory needs and ensure alignment across divisions


• Prepare, review, and submit regulatory documentation, including submissions, reports, and correspondence with regulatory authorities


• Identify and mitigate regulatory risks associated with the spin-off process


• Communicate effectively with internal and external stakeholders, providing updates on project status and regulatory developments


• Provide regulatory guidance and training to cross-functional teams to ensure compliance and understanding of regulatory requirements

REQUIREMENTS:

• Regulatory Affairs Project Manager with experience and familiarity with manufacturing, supply chain, labeling, etc.


• The candidate will ideally come from Pharma, MedTech, or Medical Device Industries


• Strong PM skills, including the ability to coordinate tasks/deliverables across multiple workstreams


• Excellent communication skills to transfer business requirements into data outputs


• Ability to work effectively across multinational and multicultural environments


• Collaboration with multiple stakeholders in order to meet deadlines


• Experience with MS Excel, PowerPoint, Word, and Power BI

Nice to Have Skills:

• Ability to understand Regulatory Affairs requirements/landscape


• Ability to summarize data into reports/presentations for senior level stakeholders


• Experience in managing complex matrixed business environments

The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.

We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.

Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless
and until paid and may be modified in its discretion consistent with the law.

This job is not eligible for bonuses, incentives or commissions.

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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