Job Description :
Our client is looking for a Regulatory Affairs(Lead) for long term project in Bridgewater, NJ, below is the detailed requirement.

Job Title : Regulatory Affairs(Lead)
Location : Bridgewater, NJ
Duration : Long term

Job Description:
· Bachelor’s/Diploma in pharmacy & life-science or equivalent, with minimum 9+ years of relevant experience.
· Minimum 5 years experience in electronic submission publishing, routine IND maintenance submissions.
· Minimum 5yrs electronic submission publishing tools a must (eCTD, Insight and eCTD submission publishing.
· Experience in regulatory affairs knowledge of drug development and drug lifecycle management.
· You should have different submission procedures (US, Caribbean, South America & Canada )
· Good understanding in clinical Practice (GCP) ? 21 CFR part 11.
· Minimum 3-5Yrs experience in people management is added advantage
· Demonstrate excellent communication skills including the ability to effectively communicate with internal and external customers.
· Ability to use strong industry knowledge to relate to customer needs and dissolve customer concerns and high level of focus and attention to detail.
· Strong work ethic with good time management with ability to work with diverse teams.