THE OPPORTUNITY
Parnell is on an exciting growth trajectory and we’re looking for a Regulatory Affairs Manager or Director to join our team.
This role can be based in our Kansas City office and/or fully remote position with the expectation that you may be required to travel to our Kansas City office from time to time.
We welcome applicants ranging from Manager to Director level.
We are seeking an experienced Regulatory Affairs Manager or Director to lead our regulatory function and drive the successful development, approval, and lifecycle management of our veterinary pharmaceutical products.
This is a pivotal role, working closely with senior leadership, Manufacturing, Quality, and external partners to ensure our products meet all regulatory requirements while supporting business growth.
The role will report directly to V.P., Regulatory Affairs based in the US.
WHAT YOU'LL BE DOING
- Lead the review and approval of regulatory documents and reports submitted to regulatory authorities (including APVMA, ACVM, FDA-CVM and other relevant bodies), ensuring accuracy, compliance, and timely delivery
- Develop and communicate clear regulatory strategies in partnership with cross-functional teams to drive successful product outcomes
- Oversee the preparation, review, and approval of new product applications (NADA/ANADA/INAD), amendments, license renewals, import/export permits, annual reports, supplements and variations, animal ethics compliance documentation, and product labelling/label changes
- Serve as the primary liaison with regulatory authorities, building strong working relationships and negotiating effectively to meet regulatory requirements
- Cultivate collaborative relationships with internal teams and external partners, including vendors, consultants, CMOs, and regulators to support seamless submissions, approvals, and documentation
- Partner closely with Manufacturing Operations, Quality, and senior leadership to resolve complex regulatory challenges and support production and CMO opportunities
- Manage the full regulatory lifecycle of company products, including post-approval activities and pharmacovigilance, proactively flagging emerging issues to leadership and sharing regulatory insights across the organization
ABOUT YOU
You’re a proactive, solutions-focused and enthusiastic individual who takes pride in your work and thrives in a fast-paced, regulated environment. You bring:
- Deep knowledge of APVMA, ACVM, and FDA-CVM regulatory requirements and submission types (NADA, ANADA, INAD, VFD), with a track record of direct interactions with regulatory authorities
- Bachelor's degree in life sciences, veterinary science, or a related field
- 8-10+ years of progressive regulatory affairs experience within veterinary or animal health pharmaceuticals, including experience in a leadership capacity
- Strong understanding of quality systems (GMP) and experience supporting or leading regulatory inspections and audits
- Excellent communication and negotiation skills, with the ability to build trusted relationships with regulators, partners, and internal stakeholders
WHY PARNELL?
We’re not your average pharmaceutical company. Parnell is a globally operating animal health business on an upward trajectory and we’re building the team that will take us there.
You’ll matter here. As part of a close-knit, high-performing team, your contributions directly shape outcomes for the animals and customers we serve.
You’ll be part of something meaningful, delivering animal health solutions that make a real, measurable difference to our customer’s success.
You’ll work alongside people who share your commitment to Professionalism, Excellence, Teamwork, and Safety and Sterility.
WHO ARE WE?
Parnell Veterinary Pharmaceuticals is a globally operating animal health company with a pharmaceutical manufacturing facility in Alexandria, Sydney, a manufacturing facility in Menomonie, WI, and a dynamic corporate hub in Kansas City driving commercial operations, sales, marketing, digital technology, and corporate services.
We are passionate about pushing the boundaries of animal health partnering with veterinarians, producers, and pet parents to deliver innovative, differentiated solutions that create real, measurable improvements. Bold ideas and continuous improvement aren’t just welcomed here, they’re expected!
Parnell is an equal opportunity employer that values diversity and inclusion. We encourage candidates from all backgrounds to apply. Only successful candidates will be contacted for interview.
Pay: From $90,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Paid time off
- Parental leave
- Referral program
- Vision insurance
Work Location: Remote