Argenta is currently looking to fill the role of Senior Regulatory Affairs Manager within our CRO Americas division.
About the role:
- Facilitates and supports the regulatory and drug development requirements of external clients and internal projects
- Effectively manage client and stakeholder expectations by providing timely, relevant, and accurate documents, assessments, reports and communications
- Demonstrates an awareness of current regulations, guidance's, regulatory processes, and the animal drug development process, while maintaining a flexible and creative mindset to work through regulatory challenges
- Creates regulatory solutions to complex issues
- Provides client accurate expert regulatory advice on animal health product development
- Represent Argenta in industry associations (e.g. GADA, AHI, SQA)
- Identify and pursue new regulatory consulting opportunities which may include meeting with new clients, traveling and speaking at professional meetings, networking in the industry and contributing to various publications
Requirements:
- Bachelor's degree or equivalent experience in a scientific discipline, advanced degree (DVM, PhD, MS) is preferred
- 8+ years experience in veterinary regulatory and/or animal drug development
- Proven experience includes several of the following: CVM, E-Submitter, GLP, GCP, GMP, USDA, EPA, EMA
- Development and regulatory experience with food animal drugs is preferred but not required
- Good written and oral communication skills, and ability to work collaboratively within and across teams
- Results and bottom line oriented
- Excellent analytical skills and attention to detail
- Proven influence, negotiation and persuasion skills
- Defines and plans priorities well. Comfortable balancing shifting priorities as required to meet business needs
You will also be someone who is aligned with our company values of "We are Doers, We are Team Players, We are Innovators, We are Customer-Centric".
We pride ourselves on the uniqueness of our development and manufacturing abilities and the skills and qualities of our team.
The position is a remote position working out of your home with domestic and occasionally international travel. Due to the nature of being a global organization, there may be times when this role works outside of normal business hours. Those times would be provided to the employee with plenty of notice.
Want to know more about Argenta? Visit our website www.argentaglobal.com
