Job DetailsThe Senior Regulatory Affairs Specialist supports US regulatory activities for Animal Health pharmaceutical and biological products. The role provides hands-on support across product labeling, regulatory operations, lifecycle management, regulatory submissions, product stewardship, and compliance activities.
The position works closely with internal and client stakeholders to ensure regulatory activities are completed accurately, compliantly, and within required timelines.
Responsibilities:- Support US labeling activities for Animal Health pharmaceutical and biological products.
- Coordinate labeling development, review, approval, implementation, and maintenance.
- Prepare and coordinate regulatory submissions, registrations, annual reports, and postapproval changes.
- Support regulatory operations, document workflows, submission tracking, and records management.
- Maintain regulatory documentation, correspondence, trackers, and product information.
- Support lifecycle management and product stewardship activities.
- Evaluate product, labeling, manufacturing, and quality changes for potential regulatory impact.
- Collaborate with Regulatory Affairs, Quality, Manufacturing, Pharmacovigilance, Supply Chain, and Commercial teams.
- Support onboarding, training, knowledge transfer, and regulatory-system activities.
- Ensure assigned deliverables comply with applicable procedures and regulatory requirements.
- Manage multiple priorities and communicate potential risks or delays promptly.
- Support other US regulatory consulting activities as business needs evolve.
#LI-AT2
Education:- Bachelor's degree in a scientific, regulatory, pharmaceutical, or related discipline.
- Certification in clinical research or regulatory affairs preferred. Certification in data analytics or scientific data interpretation tools preferred.
Experience:- Five or more years of regulatory affairs, regulatory operations, labeling, pharmaceutical, biologics, vaccines, or related experience.
- Experience supporting regulatory submissions, labeling, lifecycle management, or regulatory operations.
- Experience working with cross-functional teams in a regulated environment.
Skills:- Strong documentation, organization, communication, and problem-solving skills.
- Ability to manage multiple assignments and work independently.
What Cencora offersWe 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
Affiliated CompaniesAffiliated Companies: Cencora Global Consulting Services US Corporation
