Job Requirements
MINIMUM QUALIFICATIONS:
A Bachelor of Science Degree in Life Science or a related field. An advanced degree is preferred.
A minimum of 6 years experience in (a PHARMACEUTICAL regulatory environment or CRO or Biopharmaceutical industry (CFR parts 210/211-Delete this reference to the regulations), including start-up of contract manufacturers, regulatory compliance and submissions.
Working knowledge of regulatory affairs and the FDA, current cGMPs/GCPs and GLPs, PHARMACEUTICAL product testing requirements, FDA and ICH guidelines.
Strong hands-on experience with worldwide regulatory planning and submission preparation and negotiation.
A Regulatory Affairs Certification (RAC) is preferred, but not required.
Strong organizational skills, basic computer skills (i.e. Word, Excel, Internet, Lotus Notes, QUMAS, Trackwise) and communication skills.
Travel 10% of the time is required, both domestic and international.
Ability to work in worldwide, multicultural organization.
PHYSICAL REQUIREMENTS:
Able to use standard computer equipment.
Able to stand and sit for minimum 15 minute periods.
WORKING CONDITIONS:
Occasional exposure to PHARMACEUTICAL manufacturing environment.
Travel is required.
