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Rick Foster
Global Regulatory Affairs Manager
Summary
As a seasoned Global Regulatory Affairs Manager with over 8 years of experience, I have played a pivotal role in ensuring regulatory compliance for multiple, high-profile medical device and pharmaceutical products across global markets. My deep understanding of international regulations and ability to lead cross-functional teams have consistently resulted in successful product launches and market approvals.
My expertise in global regulatory compliance encompasses FDA, EMA, and various international regulations. I am adept at developing and implementing comprehensive regulatory affairs programs, including clinical trial protocols, INDs, and marketing applications. Furthermore, I excel at conducting regulatory assessments, due diligence, and post-market surveillance.
Throughout my career, I have collaborated closely with legal and scientific affairs to provide regulatory guidance and support throughout the product development lifecycle. My proactive approach to monitoring regulatory changes and industry trends has enabled me to anticipate and mitigate risks, ensuring compliance and safeguarding product approvals.
Education
Masters of Science in Regulatory Affairs
August 2016
Skills
- Global Regulatory Compliance
- Medical Device Regulations
- Pharmaceutical Regulatory Affairs
- Clinical Trial Management
- Quality Assurance
- Risk Management
Work Experience
Global Regulatory Affairs Manager
- Monitored regulatory changes and industry trends, providing proactive guidance to ensure compliance and mitigate risks.
- Successfully obtained market approvals for multiple products in key global markets, including the US, EU, and Japan.
- Led negotiations with regulatory agencies to resolve complex regulatory issues and secure marketing authorizations.
- Developed and implemented quality systems and risk management processes to ensure compliance with regulatory requirements.
Global Regulatory Affairs Manager
- Managed global regulatory strategy for new product launches, ensuring compliance with FDA, EMA, and other international regulations.
- Developed and implemented comprehensive regulatory affairs programs, including clinical trial protocols, INDs, and marketing applications.
- Led crossfunctional teams to conduct regulatory assessments, due diligence, and postmarket surveillance.
- Collaborated with legal and scientific affairs to provide regulatory guidance and support on product development and commercialization.
Accomplishments
- Led the development of a global regulatory strategy for a new product launch, resulting in a successful market entry in over 30 countries
- Negotiated favorable regulatory approvals for a complex drug product, accelerating its timetomarket by 6 months
- Established a regulatory intelligence system that improved risk assessment and decisionmaking by 20%
- Managed a team of regulatory professionals, providing strategic guidance and ensuring compliance with global regulations
- Successfully defended regulatory challenges, preserving product market access and minimizing business impact
Awards
- Received the Regulatory Affairs Excellence Award for outstanding contributions to the field
- Recognized with the Industry Leadership Award for innovative approaches to regulatory compliance
- Honored with the Global Regulatory Champion Award for exceptional advocacy and collaboration within the industry
- Received the Regulatory Compliance Star Award for adhering to the highest industry standards
Certificates
- Certified Regulatory Affairs Professional (CRAP)
- Certified Medical Device Regulatory Affairs Specialist (CMDRAS)
- ICH GCP Certification
- ISO 13485 Lead Auditor Certification
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Essential Experience Highlights for a Strong Global Regulatory Affairs Manager Resume
- Managed global regulatory strategy for new product launches, ensuring compliance with FDA, EMA, and other international regulations.
- Developed and implemented comprehensive regulatory affairs programs, including clinical trial protocols, INDs, and marketing applications.
- Led cross-functional teams to conduct regulatory assessments, due diligence, and postmarket surveillance.
- Collaborated with legal and scientific affairs to provide regulatory guidance and support on product development and commercialization.
- Monitored regulatory changes and industry trends, providing proactive guidance to ensure compliance and mitigate risks.
- Successfully obtained market approvals for multiple products in key global markets, including the US, EU, and Japan.
- Led negotiations with regulatory agencies to resolve complex regulatory issues and secure marketing authorizations.
Frequently Asked Questions (FAQ’s) For Global Regulatory Affairs Manager
What is the role of a Global Regulatory Affairs Manager?
A Global Regulatory Affairs Manager is responsible for ensuring that a company’s products comply with all applicable regulatory requirements in the markets where they are sold. This involves working with regulatory agencies around the world to obtain marketing approvals, conducting clinical trials, and monitoring post-market surveillance data.
What are the qualifications for a Global Regulatory Affairs Manager?
A Global Regulatory Affairs Manager typically has a bachelor’s or master’s degree in a related field, such as science, law, or business. They also have several years of experience working in the regulatory affairs field, with a deep understanding of the regulatory requirements for medical devices and pharmaceuticals.
What are the key skills for a Global Regulatory Affairs Manager?
A Global Regulatory Affairs Manager should have excellent communication and interpersonal skills, as they will need to work with people from a variety of backgrounds, including scientists, lawyers, and businesspeople. They should also be able to work independently and as part of a team, and be able to manage multiple projects simultaneously.
What is the career outlook for a Global Regulatory Affairs Manager?
The career outlook for a Global Regulatory Affairs Manager is expected to be good over the next few years, as the demand for medical devices and pharmaceuticals continues to grow. More and more companies are expanding their global reach, and they need qualified professionals to help them navigate the complex regulatory landscape.
What are the salary expectations for a Global Regulatory Affairs Manager?
The salary for a Global Regulatory Affairs Manager can vary depending on a number of factors, including experience, location, and company size. However, the average salary for a Global Regulatory Affairs Manager in the United States is around $100,000 per year.