Job Description :
Our client is looking for a Sr. Publisher – Regulatory Affairs for full time project in Bridgewater NJ, below is the detailed requirement.

Job Title : Sr. Publisher – Regulatory Affairs
Location : Bridgewater, NJ
Duration : Full time

Job Description:
· Bachelor’s degree in Pharma, Life Science or equivalent, with minimum 8+ years of relevant experience.
· Minimum 2-4 years of experience in the pharmaceutical industry, with relevant experience in electronic submission publishing, routine IND maintenance submissions, dossier management and dispatch of global drug dossiers.
· Experience with electronic document management systems, submission publishing tools, knowledge of documents publishing/document management including, Adobe Acrobat.
· Expert in HA (Health Authority) submission publishing requirements globally.
· Good in Regulatory Publishing to prepare the Clinical Documents (written by the Med. Writers) for submission through eCTD gateway
· Strong understanding in Compiling and maintaining regulatory documents as per the procedure in client repository.
· Experience in global regulatory submission / dossier publisher day-to-day activities and deliverables
· Strong knowledge of regulatory processes and related tools (document management, publishing, etc.
· Ability to be a mentor/trainer to Jr. Publishers
· 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.