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Manager, Global Regulatory Affairs (Pharma)

Manager of Regulatory Affairs - Southern CT The Regulatory Affairs Manager is responsible for overseeing the Hospital’s compliance program across the Health System. They lead investigations, complete Cause Analyses/Plans of Correction, and promote a culture of safety and quality care. Compliance is crucial to achieving organizational goals and maintaining our vision as a trusted healthcare partner.QUALIFICATIONS/REQUIREMENTS:• Bachelor’s Degree in nursing or healthcare is required.• Master’s Degree Preferred.• Valid CT RN or other health care license.• Ability to accurately complete and analyze regulatory data, produce accurate and detailed written reports.• 3 to 5 years of prior regulatory compliance experience in an acute care setting is required.• 3-5 years’ prior leadership experience which may include supervisor or team lead roles.• Excellent written, oral and communication skills are essential.• Demonstrated organization skills are essential.• Expertise in the utilization of quality improvement methods related to data management and analysis is required.• Experience developing and conducting educational programs.APPLY NOW! OR reach out to Megan directly at 617-746-2768 (accepts texts) / Megan@ka-recruiting.com. OR schedule a quick call with Megan using this link: calendly.com/megankarecruiting

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What You Should Know About Manager, Global Regulatory Affairs (Pharma), ChromaDex

As the Manager of Global Regulatory Affairs at our esteemed pharmaceutical company in Georgia, you'll take the helm of a dynamic team dedicated to ensuring our compliance program is not just effective but transformative. Your expertise will allow you to lead investigations and conduct thorough Cause Analyses, and Plans of Correction that are essential in fostering a culture of safety and quality care within our health system. We believe compliance is more than a checkbox; it’s a vital part of our mission to be a trusted healthcare partner. You’ll leverage your strong background in nursing or healthcare, ideally complemented by an advanced degree, as you collaborate with various departments to uphold and elevate our standards. Your role will primarily involve analyzing regulatory data, crafting detailed reports, and utilizing your exceptional communication skills to educate teams on compliance protocols. With 3 to 5 years of regulatory compliance experience in an acute care setting under your belt, you’re well-prepared to inspire and lead our initiatives in quality improvement. If you have a passion for nurturing talent and advancing organizational goals in a healthcare environment, we want to hear from you!

Frequently Asked Questions (FAQs) for Manager, Global Regulatory Affairs (Pharma) Role at ChromaDex
What are the key responsibilities of the Manager, Global Regulatory Affairs at our pharmaceutical company in Georgia?

The Manager, Global Regulatory Affairs at our pharmaceutical company in Georgia is primarily responsible for overseeing compliance programs across our health system. This includes leading investigations into compliance issues, completing Cause Analyses, and developing Plans of Correction. Additionally, you'll promote a safety and quality care culture while ensuring the organization meets its regulatory obligations.

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What qualifications do I need to apply for the Manager, Global Regulatory Affairs position?

To apply for the Manager, Global Regulatory Affairs position at our Georgia-based pharmaceutical company, you must have a Bachelor’s Degree in nursing or healthcare. A Master’s Degree is preferred. Additionally, you should possess a valid healthcare license and 3 to 5 years of experience in regulatory compliance within an acute care setting.

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What experience is necessary for the Manager, Global Regulatory Affairs role in Georgia?

Candidates for the Manager, Global Regulatory Affairs position in Georgia should ideally have 3 to 5 years of regulatory compliance experience in an acute care environment, coupled with leadership experience in supervisor or team lead roles. This background is crucial for effectively managing regulatory affairs in a healthcare setting.

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How does the Manager, Global Regulatory Affairs contribute to a culture of safety at our company?

As the Manager, Global Regulatory Affairs, you'll play a pivotal role in shaping a culture of safety within our company by conducting compliance investigations and educational programs. Your leadership will ensure that staff understands the importance of regulatory adherence, thereby fostering an environment dedicated to quality care and patient safety.

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Can I reach out to someone for more information about the Manager, Global Regulatory Affairs position?

Absolutely! You can contact Megan directly at 617-746-2768 via text or email her at Megan@ka-recruiting.com for more information about the Manager, Global Regulatory Affairs position at our pharmaceutical company in Georgia.

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Common Interview Questions for Manager, Global Regulatory Affairs (Pharma)
Can you explain your previous experience in regulatory compliance?

In answering this question, focus on specific experiences where you managed compliance-related tasks, details of the investigations you led, and how those experiences have prepared you for the Manager, Global Regulatory Affairs role.

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How do you ensure that your team adheres to regulatory guidelines?

Discuss strategies you've implemented for educating and training team members, and mention how you foster an open environment for discussing compliance challenges to encourage adherence.

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What methods do you use to analyze regulatory data?

Offer examples of the tools and techniques you've used for data analysis, and how you ensured the accuracy of that data. Highlight your attention to detail and analytical skills.

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Can you provide an example of a compliance issue you resolved?

Share a specific instance where you identified a compliance issue, the steps you took to investigate it, the resolution you achieved, and what you learned in the process.

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How do you prioritize tasks in a fast-paced regulatory environment?

Describe your process for identifying critical tasks and how you manage time effectively while staying organized under pressure. Use specific examples from your previous experience to illustrate your methods.

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What role does team communication play in regulatory compliance?

Emphasize the importance of clear and open communication among team members in ensuring compliance. Discuss how you've facilitated communication to address issues and promote best practices.

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How do you keep abreast of changes in regulatory policies?

Talk about specific resources you utilize, such as industry publications, professional associations, or online courses, to remain updated on regulatory changes that may impact your organization.

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What experience do you have with quality improvement methods?

Highlight any methodologies you've employed, such as Lean or Six Sigma, and provide examples of how you've applied these methods to enhance compliance processes.

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How do you handle resistance to compliance measures from staff?

Explain your approach to addressing staff concerns about compliance measures through education, support, and open dialogue. Share examples of successfully implementing changes despite pushback.

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What motivates you to work in regulatory affairs?

Convey your passion for healthcare, patient safety, and the importance of regulatory compliance in building trust and quality care within the organization. Share personal anecdotes or motivations that drive you.

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Founded in 1999, ChromaDex develops and manufactures nutriceuticals. ChromaDex is headquartered in Los Angeles, California.

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Full-time, on-site
DATE POSTED
December 13, 2024

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