Manager | AD, Regulatory Affairs Pharma Safety & Efficacy
Boehringer Ingelheim2 days ago
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OnsiteFull-timeMid
Summary
Boehringer Ingelheim is seeking a Manager | AD, Regulatory Affairs Pharma Safety & Efficacy to join their team in Duluth, GA. The role involves representing the US regulatory safety and efficacy function in global development projects and providing regulatory strategy for product approval.
About the Role
As a Manager in Regulatory Affairs, you will be responsible for the safety and efficacy part of the dossier for new veterinary products and life-cycle management of existing products. You will coordinate technical input for product labeling, provide regulatory advice to project teams, and represent the company at external functions. Additionally, you will link regulatory affairs information to stakeholders and ensure compliance with US regulations.
About You
Required:
- Advanced degree (Doctor of Veterinary Medicine or PhD) with minimum two years related experience in Regulatory Affairs or equivalent experience in the pharmaceutical industry, or a Master's degree with minimum seven years related experience.
- Excellent command of English language, both written and spoken.
- Regulatory Affairs or equivalent pharma industry experience is required.
- Ability to collaborate in a global organization and manage multiple projects.
Preferred:
- Advanced degree from an accredited institution with a minimum of five years related experience in Regulatory Affairs strategy/execution.
- Sound knowledge of the legal requirements for approval of veterinary medicinal products.
- Demonstrated ability to successfully collaborate in a global organization.
Benefits
- Competitive compensation and benefits package.
- Opportunities for career development and international collaboration.
- Support for a healthy working environment and work-life balance.
Boehringer Ingelheim
Our people are our strength. And, together with over 53,000 colleagues, we're creating the next breakthrough in the world of health and innovation for both humans and animals. Are you ready to join us? #LifeForward Privacy Notice: https://www.boehringer-ingelheim.com/privacy-notice Imprint: https://www.boehringer-ingelheim.com/imprint
Duluth, GA