Manager, Regulatory Affairs - Pharmaceuticals

March 17

🌽 Illinois – Remote

Although this job is listed in Illinois, this company may be open to hiring remote in other states.

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

+2 more states

🌽 Illinois – Remote 🌲 North Carolina – Remote 🍂 Massachusetts – Remote 🤠 Texas – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Fresenius Medical Care

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Fresenius Medical Care is a global health care company specializing in providing products and services for individuals with renal diseases. Founded in 1996, Fresenius Medical Care is the leading provider of dialysis treatment, building on the expertise of its parent company, the Fresenius health care group. The company is dedicated to improving the quality of life for patients worldwide by delivering high-quality care and innovative renal therapies. With a global presence, Fresenius Medical Care operates over 4,000 dialysis clinics and employs more than 125,000 people. The company's core values include collaboration, proactivity, reliability, and excellence, fostering a diverse and inclusive work environment to support its mission in delivering superior patient care.

dialysis • hemodialysis • home dialysis • kidney disease • renal care

10,000+ employees

Founded 1996

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🔬 Science

📋 Description

• This is a fully remote position. • This person should be a subject matter expert on Regulatory Affairs as it relates to HealthCanada. • Provides regulatory input to facilitate the timely preparation and submission of the required information to applicable agencies specializing in Canadian regulatory affairs. • Manage the company's pharmaceutical products with a specialty in Canadian Regulatory Affairs. • Facilitates regulatory strategy development and other compliant alternatives for the product team to register products globally, focusing on Canada. • Offer guidance to departments on how to design, develop, evaluate, and market products in Canada. • Authoring, reviewing, and coordinating quality submissions to regulatory agencies (Health Canada). • Extensive knowledge of applicable government regulations with a focus on Canada.

🎯 Requirements

• 6 – 8 years’ related experience. • 3+ years’ supervisory or project/program management experience preferred. • Breadth of desired pharmaceutical experience includes: contact with manufacturing, quality, clinical and preclinical departments. • Required skills include a history of demonstrated success working effectively in a highly charged, stressful, and changing environment. • Knowledge, comprehension and application of scientific principles are required. • Must be knowledgeable of and have experience in applying FDA drug regulations. • Possess strong oral and written communication skills. • Computer proficient. • Experience in regulatory publishing templates highly desirable.