The ideal candidate should
possess an updated
knowledge of the current FDA, COFEPRIS, USP and ICH guidelines,
Hatch- Waxman Act, Drug User-Fee Act(s), Drug Supply
Chain Security Act (DSCSA) and other relevant
laws governing pharmaceutical industry. An ideal candidate should have
sound understanding of various pharmaceutical dosage forms and pharmaceutical
science along with pharmaceutical manufacturing process.
- Under the direction of management, to represent the US Animal Health Regulatory Affairs Pharmaceutical group on cross-functional pharmaceutical and/or biopharmaceutical project team(s), primarily companion animal species, providing strategic, proactive and timely regulatory expertise throughout the planning and execution of the project(s) or other related tasks.
- Be primary point of contact for interactions with the Food and Drug Administration (FDA)/Center for Veterinary Medicine (CVM) in relation to the assigned products/projects. Will ensure that questions or requests are addressed in a timely manner.
- To work with project team members, to develop content and structure of high quality regulatory submissions that fulfill regulatory requirements and the expectations of regulatory agency personnel.
- To author or co-author high quality regulatory component documents used in the production of submissions that comply with regulatory requirements and expectations of regulatory agencies (primarily FDA/CVM) .
- Responsible for providing strategic and tactical guidance throughout the planning/execution of projects.
- Facilitate establishment inspections of API & Finished Dosage Form manufacturing sites.
- Provide QA oversight to with respect to agreement and audit of all 3PL service providers, re-packagers, contract manufacturing organizations and contract research organizations.
- Manages compliance within the department by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to.
- Develops, translates, reviews (if relevant) and approves artwork and promotional copy to ensure regulatory compliance for submissions.
- Uses available electronic publishing tools to compile, electronic or paper-based submissions necessary to meet regulatory requirements.
- Provides executive summaries and status updates on product/project activities to key internal/external stakeholder.
- Excellent oral and written communication and negotiation skills.
- Very organized with strong attention to detail.
- Functional knowledge of Microsoft platforms and associated Office suite programs that may include but are not limited to Outlook, Word, Excel and PowerPoint.
- Experience with electronic submissions to regulatory authorities and/or project management experience would be a bonus.
or Master’s degree, in a relevant scientific discipline (animal science,
veterinary medicine, immunology, toxicology/pharmacology or similar). DVM
and/or PhD is highly desirable.
of three years’ experience in the animal health pharmaceutical or
biopharmaceutical product development industry.
affairs knowledge (especially regarding registration of animal health products
with FDA-CVM), experience in developing regulatory submissions, and interacting
with regulatory agency personnel are highly desirable. Experience in dealing
with development and/or registration of biopharmaceutical products with