- Collaborate with internal teams and regulatory agencies
- Lead and manage regulatory activities
- Ensure compliance with global regulations and standards
- Prior experience in pharmaceuticals, human nutrition, or medical device industries
- Experience with major regulatory and government agencies like USDA, APHIS, and FDA
- Strong people development and decision-making skills
- Educational background in relevant disciplines
- Minimum 6 years of regulatory experience
- Proficiency in MS Office, eQMS, and regulatory requirements
- Attention to detail
- Effective communication skills
- Ability to work collaboratively
- Strong analytical and organizational skills
- Strategic Liaison
- Regulatory Leadership
- Submission Management
- Monitoring and Communication
- Compliance and Quality Systems
- Collaboration and Coordination
- Stakeholder Engagement
- Documentation and Training
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Senior Manager, Regulatory Affairs - Ankeny, United States - Lauridsen Group Inc.
Description
The Senior Manager of Regulatory Affairs at Proliant Health & Biologicals (PHB) plays a vital role in ensuring PHB products comply with local and international regulations within key markets such as diagnostics, therapeutics, and nutrition. In this position, you will work closely with regulatory agencies, cross-functional teams, and stakeholders to develop and implement regulatory strategies.
About the Job:
Job Qualifications:
Key Skills:
Key Responsibilities:
About Proliant Health & Biologicals (PHB):
Founded in 1916 as the Lauridsen Creamery, PHB has grown to be a global entity with manufacturing and sales locations in over twenty countries. The company values independence, entrepreneurship, and innovation to constantly add value to its products and applications.