Requisition ID 16064BR
Title Sr. Associate, Regulatory Affairs
Job Category Regulatory Affairs
Job Description PURPOSE:
Assist more experienced regulatory affairs personnel on projects associated with assigned therapy areas. Functions in accordance with supervisor’s guidance.
RELATIONSHIPS:
Reports to the Associate Director on assigned projects. Works with other project team members, including US Marketing, CMR, Legal, and counterparts in Novo Corporate Regulatory Affairs.
ESSENTIAL FUNCTIONS:
Advise stakeholders of submission completion.
As assigned, participate in project teams.
As requested, find information/potential answers to challenging areas related to assigned projects in the interest of keeping the project streamlined and moving forward.:
Assist in preparation of regulatory documents.:
Assist Manager/Director in review of labeling for marketed products and new products as assigned.:
Assist more senior personnel in managing projects.:
Assist with technical preparation for FDA meetings, including review of draft questions and supporting documents.:
Compile applications and prepare for sign-off (INDs/NDAs/BLAs/510ks, IND amendments & Annual Progress Reports, NDA Annual Reports & Annual ADE Reports, IND Safety Reports, Drug & Establishment Listings, responses to FDA communications, among others as assigned), assure submission to government agencies in support of investigational and marketed products is completed in accordance with supervisor’s requirements and guidance.:
Coordinate document submission.:
In accordance with supervisor’s requirements & guidance:
Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guidelines, and proactively provides guidance to ROI staff as needed during ssembly of regulatory submissions.:
Manage assigned project responsibilities, compose routine draft correspondence relevant to projects as assigned, such as letters of response, transmittal and memoranda where applicable. Use of templated correspondence as appropriate, ensuring that all new information is correct.:
Obtain documents/information for regulatory submissions from various functional areas and checks for errors, missing information, legibility, translations, etc. :
Prepare drafts of routine correspondence.:
Prepare ROCs for routine FDA contacts.:
Review documents.:
Review information from US and Corporate contributing departments and provides comments to assure that documents are accurate and complete and comply with FDA regulations.:
PHYSICAL REQUIREMENTS:
Minimal overnight travel
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
A Bachelor's Degree required; (Life Science preferred) with a minimum of 3 years pharmaceutical industry experience in R&D lab, Clinical or related environments.
Effective personal time management.
Excellent written skills.
High commitment to quality of all assigned projects.
Intermediate proficiency in Microsoft Office Suite required.
Knowledge/experience with a content management system (e.g. Documentum) is highly desirable
Strong detail orientation.
Department CMR - THERAPEUTIC AREA (1a)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%
Title Sr. Associate, Regulatory Affairs
Job Category Regulatory Affairs
Job Description PURPOSE:
Assist more experienced regulatory affairs personnel on projects associated with assigned therapy areas. Functions in accordance with supervisor’s guidance.
RELATIONSHIPS:
Reports to the Associate Director on assigned projects. Works with other project team members, including US Marketing, CMR, Legal, and counterparts in Novo Corporate Regulatory Affairs.
ESSENTIAL FUNCTIONS:
Advise stakeholders of submission completion.
As assigned, participate in project teams.
As requested, find information/potential answers to challenging areas related to assigned projects in the interest of keeping the project streamlined and moving forward.:
Assist in preparation of regulatory documents.:
Assist Manager/Director in review of labeling for marketed products and new products as assigned.:
Assist more senior personnel in managing projects.:
Assist with technical preparation for FDA meetings, including review of draft questions and supporting documents.:
Compile applications and prepare for sign-off (INDs/NDAs/BLAs/510ks, IND amendments & Annual Progress Reports, NDA Annual Reports & Annual ADE Reports, IND Safety Reports, Drug & Establishment Listings, responses to FDA communications, among others as assigned), assure submission to government agencies in support of investigational and marketed products is completed in accordance with supervisor’s requirements and guidance.:
Coordinate document submission.:
In accordance with supervisor’s requirements & guidance:
Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guidelines, and proactively provides guidance to ROI staff as needed during ssembly of regulatory submissions.:
Manage assigned project responsibilities, compose routine draft correspondence relevant to projects as assigned, such as letters of response, transmittal and memoranda where applicable. Use of templated correspondence as appropriate, ensuring that all new information is correct.:
Obtain documents/information for regulatory submissions from various functional areas and checks for errors, missing information, legibility, translations, etc. :
Prepare drafts of routine correspondence.:
Prepare ROCs for routine FDA contacts.:
Review documents.:
Review information from US and Corporate contributing departments and provides comments to assure that documents are accurate and complete and comply with FDA regulations.:
PHYSICAL REQUIREMENTS:
Minimal overnight travel
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
A Bachelor's Degree required; (Life Science preferred) with a minimum of 3 years pharmaceutical industry experience in R&D lab, Clinical or related environments.
Effective personal time management.
Excellent written skills.
High commitment to quality of all assigned projects.
Intermediate proficiency in Microsoft Office Suite required.
Knowledge/experience with a content management system (e.g. Documentum) is highly desirable
Strong detail orientation.
Department CMR - THERAPEUTIC AREA (1a)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%