Regulatory Affairs Jobs

Degree in one of the life sciences or chemistry (or equivalent experience); practical experience of analytical chemistry and /or pharmaceutical manufacturing an asset

· Previous submission experience and familiarity with FDA/TPD/ICH guidelines an asset

· Experience with documentation, organizing small projects, working in a deadline environment

Diploma/Degree in Computer Application Support or Life Sciences

· Working knowledge of Canadian regulatory submission requirements, guidelines and processes

· 1-2 years of experience in preparing NDS/ANDS/Formulary submissions preferred

· Solid technical knowledge of Word and Acrobat

Education:
B.S. in laboratory animal science, biology or a related life science discipline is required. Preference for individuals with D.V.M./V.M.D or PhD degrees.

Required:
-Minimum of 5 years experience working with in vivo laboratory specimens
-Excellent interpersonal, written communication and organizational skills.
-IACUC experience

BS, MS or Ph.D. in a biological science or strongly related field such as Cell Biology, Virology, Molecular Biology or Microbiology is required (MS or PhD preferred), along with demonstrated technical expertise and experience with vaccines, cell culture, and/or virology.

BS, MS or Ph.D. in biological science or related engineering field (e.g. microbiology, virology, molecular biology, biochemistry, biochemical engineering, chemical engineering or mechanical engineering) is required. Other fields may be considered, with appropriate experience.

First degree (Science) higher degree desirable; At least 6-7 years (grade dependent) relevant experience in diagnostic and/or pharmaceutical development with biologics experience preferred.
• Strong scientific background
• Excellent organizational skills
• Excellent written and oral communication skills
• Ability to strategize, problem solve and influence in matrix team setting

D4 Qualifications:

Preferred BS degree in sciences or equivalent and 11 – 12 years experience in a FDA-regulated environment

MS/Pharm D or equivalent and 8 – 9 years in FDA-regulated environment

PhD or equivalent and 5 –6 years in FDA-regulated environment

Understand, comply, and reinforce local regulations, laws, and guidance (e.g., FDA, ICH), Global Medical Policies and Procedures, and Good Clinical Practices (GCP).

Comply with Global and Local Informed Consent Document (ICD) requirements and serve as resource for ICD creation, approval, and revision process.

Provide Regulatory expertise and consultation to study team members.

Work as part of the Regulatory Compliance team to review and approve promotional material for Global Marketing and the US Affiliate to support the food and companion animal business.

Provide regulatory guidance to both food and companion animal business units based on federal guidance and action letters, interactions with regulatory agencies and Elanco management.