- Plan, submit, and manage the dossiers and all regulatory documents presented to regulatory authorities in the region.
- Serve as the U.S. “Permittee” for IDT products manufactured outside of the jurisdiction and fulfill the U.S. requirements to import vaccines and diagnostics for transboundary animal diseases and other animal health products.
- Manage documentation incl. labels, timely submission of annual revisions, new registrations, licenses, permits and other regulatory submissions to regulatory authorities.
- Assure compliance with industry regulations.
- Communicate effectively with regulatory authorities.
- Learn and stay current as an expert on applicable regulations and legislation especially in the US and Canada.
- Interact effectively and regularly with headquarters’ regulatory group and with regional personnel.
- Support teams in developing roadmap for planned submissions and product launches, and developing new products. Write and review applicable SOPS, as necessary.
- Manage applicable audit, compliance and risk management functions.
- Bachelor’s Degree in life sciences or veterinary fields. Master’s degree preferred.
- 5+ years of experience in the life science industry, preferably in the Animal Health industry involving vaccines and/or biologics.
- 5+ years’ experience in regulatory affairs (veterinary products) and working with U.S. government agencies. Experience as a U.S. permittee a strong plus.
- Fluent in English with strong verbal and written communications skills, a second language, especially German, French or Spanish a strong plus.
- Experience in working in a cGMP environment a plus.
- Demonstrated ability to manage multiple projects/tasks. Project management experience desired.
Submit cover letter and resume to the contact person below:
Head of Human Resources, NA
1405 Research Boulevard
Rockville, MD 20850