Senior Regulatory Affairs Manager

About this role

At Argenta, we’re more than a company — we’re a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it.
Founded in 2006, we support companies big and small to develop and manufacture health products for pets and livestock. Our trusted, innovative solutions and services cover every stage of the process, from molecule to market.
We’re in a unique position. We are the world’s only combined contract research and contract development and manufacturing organisation (CRO/CDMO) dedicated to animal health.
Our uniqueness means:
We are ambitious, growing and building a ‘one team’ culture, guided by our values.
We are team players;

We are doers;

We are customer-centric;

We are innovators.

We value diversity, as a global company, we get the richness of working with different people in different places whether it be location, stages of their career, their development, their role. We believe that when everyone works together and puts their best “paw” forward we will make the lives of the animals we care for, better.
With bases in New Zealand, the US, the UK and Europe, our 650+ colleagues are driven by our partnership approach and purpose: Healthy Animals. Let’s Make It Happen, Together.
TEAM PLAYERSwho want toDOgreat work and findINNOVATIVEways to make animals lives better through ourCUSTOMER CENTRICefforts should apply.
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

This position is subject to a DEA background check post offer and at regular intervals. This position is also required to complete a post offer drug test. Both the background and drug test must comply with company standards or offers of employment will be rescinded.
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
Equal Opportunity Employer
Salary: commensurate with experienceOriginally posted on Himalayas