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About our client
Our client is a rapidly growing biotech company headquartered in the NE that is focused on the development and commercialization of various therapeutic for Cardiology.
Position	Location
Manager Regulatory Affairs	North East, USA
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Write sections of regulatory submissions 2) Manage compilation of regulatory submissions required to support clinical studies (INDs, IND amendments, annual reports, CMC amendments, etc.) as product development progresses and data is available from other departments 3) Attend weekly Project Team meetings to provide a status on regulatory submissions and correspondence with regulatory authorities 4) Respond to questions regarding regulatory issues 5) Review QA, Clinical and Pharma/Tox documents, reports, etc. for compliance with US and international government regulations 6) Write and review regulatory SOPs 7) Train staff when new SOPs are needed to maintain compliance with US and international regulations 8) Assist in preparing electronic submissions 9) Meet with Project teams as well as Product Development, QC, QA, Clinical and Pharma/Tox colleagues, to obtain investigational new drug product information 10) Write sections of regulatory submissions for the support of clinical studies of IND products worldwide
Requirements
1) BS in Analytical Chemistry, Chemistry or Biochemistry 2) 2+ years of lab experience in the pharmaceutical industry (bench chemist, analytical chemistry, QC/QA, pharmaceutical production, etc.) 3) Minimum 3 – 5 years of regulatory affairs experience in preparing regulatory submissions such as, INDs, IND amendments (CMC, Clinical and Pharm/Tox), IND annual reports, etc. to FDA and internationally 4) Experience in reviewing documents received from other members of the Project Team (stability reports, batch records, analytical test methods, etc.) to ensure that they meet cGMP and regulatory requirements 5) Experience in eCTD submissions format 6) Experience in writing, reviewing and coordinating the approval of regulatory SOPs with members of other departments and training staff (as needed) 7) Experience in radiopharmaceutical drug products a plus 8) Knowledge of New Drug Application process 9) Understanding of and experience in US FDA regulations regarding INDs, clinical studies, IND 10) Knowledge of regulatory submissions requirements for describing product development 11) In-depth knowledge of manufacturing and testing of clinical investigational drug products 12) Understanding of the regulatory submissions requirements for initiating and maintaining clinical studies 13) Ability to follow through to complete projects within timeline 14) Meticulous and dependable 15) Ability to have a good rapport with Project Team staff and coworkers, etc. 16) Good proof-reading skills 17) Proficiency in MS word, Excel and other similar software used for regulatory submissions preparation