Amerisource Bergen

Senior Regulatory Affairs Specialist - Animal Health

Amerisource Bergen$90K — $120K *
US-AnywhereRemote in Pennsylvania, US
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific discipline or related field
  • 5 to 10+ years in regulatory affairs or operations
  • Experience with animal health biologics, vaccines, pharmaceuticals, or related products
  • Familiarity with USDA-CVB and/or FDA-CVM preferred
  • Strong organizational skills and exceptional attention to detail
  • Excellent written and verbal communication skills
  • Proven ability to juggle multiple projects and priorities
  • Ability to work independently while collaborating with teams

Responsibilities

  • Support regulatory lifecycle activities for animal health biologics and pharmaceuticals
  • Prepare, coordinate, and maintain regulatory submissions and product registrations
  • Contribute to labeling strategy execution and implementation activities
  • Maintain accurate regulatory documentation and submission tracking
  • Assist with product stewardship and broader regulatory operations
  • Coordinate annual reports and post-approval compliance activities
  • Collaborate cross-functionally to achieve regulatory milestones
  • Support additional U.S. regulatory consulting projects as needed

Benefits

  • Comprehensive medical, dental, and vision care
  • Support for working families, including backup dependent care and adoption assistance
  • Infertility coverage and family building support
  • Behavioral health solutions and paid parental leave
  • Paid caregiver leave
  • Training programs and professional development resources
  • Opportunities for mentorship, volunteer activities, and involvement in employee resource groups
Full Job Description
Job Details

Senior Regulatory Affairs Specialist - Animal Health

Join a growing regulatory consulting team supporting innovative animal health products across the U.S. market.

We are seeking a seasoned Senior Regulatory Affairs Specialist - Animal Health to provide hands-on regulatory execution and operational support for animal health biological and pharmaceutical products. This is an exciting opportunity for a regulatory professional who enjoys working across the full product lifecycle and partnering with cross-functional teams to deliver compliant, timely, and high-quality regulatory outcomes.

This role will initially support the BI Vet Animal Health account, with the opportunity to expand into broader Animal Health and U.S. Regulatory consulting projects as business needs evolve.

About the Role

The Senior Regulatory Affairs Specialist is responsible for supporting U.S. regulatory affairs activities across product lifecycle management, regulatory submissions, labeling, product stewardship, regulatory operations, and compliance. This role is ideal for someone who brings strong execution skills, sound regulatory judgment, and the ability to manage multiple priorities in a client-focused environment.

You will work closely with internal and client stakeholders across Regulatory Affairs, Quality, Manufacturing, Pharmacovigilance, Supply Chain, and Commercial teams to help ensure regulatory objectives are delivered efficiently and compliantly.

What You'll Do:
  • Support regulatory lifecycle activities for animal health biologics and pharmaceutical products
  • Prepare, coordinate, and maintain regulatory submissions, product registrations, and related lifecycle documentation
  • Support labeling strategy execution, review, and implementation activities
  • Maintain accurate regulatory documentation, records, and submission tracking
  • Support product stewardship and broader regulatory operations activities
  • Coordinate annual reports, post-approval changes, and ongoing compliance activities
  • Partner cross-functionally to support the timely delivery of regulatory milestones
  • Provide support for additional U.S. Regulatory consulting projects as business needs grow and shift


What You'll Do:
  • Support regulatory lifecycle activities for animal health biologics and pharmaceutical products
  • Prepare, coordinate, and maintain regulatory submissions, product registrations, and related lifecycle documentation
  • Support labeling strategy execution, review, and implementation activities
  • Maintain accurate regulatory documentation, records, and submission tracking
  • Support product stewardship and broader regulatory operations activities
  • Coordinate annual reports, post-approval changes, and ongoing compliance activities
  • Partner cross-functionally to support the timely delivery of regulatory milestones
  • Provide support for additional U.S. Regulatory consulting projects as business needs grow and shift


What We're Looking For:
  • Bachelor's degree in a scientific discipline or related field
  • 5 to 10+ years of experience in regulatory affairs or regulatory operations
  • Experience supporting Animal Health, biologics, vaccines, pharmaceuticals, or related regulated products
  • Familiarity with USDA-CVB and/or FDA-CVM preferred, but not required
  • Strong organizational skills with exceptional attention to detail
  • Excellent written and verbal communication skills
  • Proven ability to manage multiple projects, deadlines, and competing priorities
  • Ability to work independently while collaborating effectively with cross-functional teams


Why This Opportunity Stands Out:

This is more than a traditional regulatory role. It is an opportunity to join a dynamic consulting environment where your expertise will support meaningful animal health programs and where your scope can grow over time. If you are looking for a role that offers variety, visibility, and the chance to make an impact across multiple regulatory initiatives, this could be a strong next step in your career.

Ideal Candidate:

You are a proactive, solutions-oriented regulatory professional who enjoys balancing detail-oriented execution with cross-functional collaboration. You are comfortable navigating complex regulatory processes, maintaining high-quality documentation, and driving work forward in a fast-paced environment.

Apply Now

If you are passionate about advancing animal health products and bringing strong regulatory execution to a growing consulting team, we encourage you to apply.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

Full time

About Amerisource Bergen

AmerisourceBergen Corporation is a pharmaceutical distribution company headquartered in Chesterbrook, Pennsylvania. It was founded in 2001 through the merger of AmeriSource Health Corporation and Bergen Brunswig Corporation. The company distributes a wide range of pharmaceutical products, including brand-name and generic drugs, specialty drugs, and over-the-counter medications. AmerisourceBergen serves healthcare providers, including hospitals, pharmacies, and physician practices, as well as pharmaceutical manufacturers. The company is committed to sustainability and has implemented several initiatives to reduce its environmental impact.
Learn more about Amerisource Bergen
Size
21,000 employees
Industry

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