Manager, Regulatory Affairs
Growing Pharmaceutical company in mercer County, NJ is looking for a Manager, Regulatory Affairs.
Permanent position with a great company.
Manager will work independently and within a group setting to act as liaison between Regulatory Affairs and other functional areas including external CROs, partners, and consultants in the planning, organizing, and preparing of regulatory documents for submission to governmental regulatory agencies This job will have the following
Responsibilities:
Prepare, coordinate, manage or maintain simple and complex regulatory submissions (e.
g.
, INDs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages, etc.
) in accordance with applicable regulations; this includes ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival).
Provide thoughtful & accurate comments during document (e.
g.
, IB, protocol, ICFs, DSURs, annual reports, etc.
) review, mindful of regulatory/ICH guidance/requirements pertaining to document content.
Interface with external regulatory groups (e.
g.
, CRO, partner, consultants, etc.
) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions.
Act as liaison between Regulatory Affairs and other functional areas; represent Regulatory Affairs in cross-functional team meetings.
Provide regulatory support for clinical operations activities (e.
g.
, review of essential documents, and development and review of consent forms, etc.
).
Monitor company progress toward fulfillment of regulatory commitments.
Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments.
Review and communicate current & emerging regulatory requirements (e.
g.
, US and international regulations and guidelines).
Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements and provide regulatory support for corporate quality assurance efforts.
Actively contribute to the development and implementation of regulatory strategy for assigned projects.
Develop and maintain current regulatory knowledge Qualifications & Requirements:
Bachelor's degree in a scientific discipline or equivalent.
Advanced degree or Regulatory Affairs Certification is preferred.
Candidate must possess a Candidate must have at least 3 to 7 years of Regulatory experience in the pharmaceutical or biotechnology industry, with demonstrated increasing expertise and responsibility Experience working with innovator products and designing and executing creative development strategies are highly desirable Experience with regulatory submissions, including INDs, international clinical trial applications, and marketing applications in Common Technical Document format, is essential.
Candidates must be local and commutable to Mercer County, NJCandidates must be authorized to work in the US for any employerFor complete details and consideration, please apply here or email your resume to email removed and reference job number:
440851.
Estimated Salary: $20 to $28 per hour based on qualifications.
Permanent position with a great company.
Manager will work independently and within a group setting to act as liaison between Regulatory Affairs and other functional areas including external CROs, partners, and consultants in the planning, organizing, and preparing of regulatory documents for submission to governmental regulatory agencies This job will have the following
Responsibilities:
Prepare, coordinate, manage or maintain simple and complex regulatory submissions (e.
g.
, INDs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages, etc.
) in accordance with applicable regulations; this includes ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival).
Provide thoughtful & accurate comments during document (e.
g.
, IB, protocol, ICFs, DSURs, annual reports, etc.
) review, mindful of regulatory/ICH guidance/requirements pertaining to document content.
Interface with external regulatory groups (e.
g.
, CRO, partner, consultants, etc.
) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions.
Act as liaison between Regulatory Affairs and other functional areas; represent Regulatory Affairs in cross-functional team meetings.
Provide regulatory support for clinical operations activities (e.
g.
, review of essential documents, and development and review of consent forms, etc.
).
Monitor company progress toward fulfillment of regulatory commitments.
Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments.
Review and communicate current & emerging regulatory requirements (e.
g.
, US and international regulations and guidelines).
Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements and provide regulatory support for corporate quality assurance efforts.
Actively contribute to the development and implementation of regulatory strategy for assigned projects.
Develop and maintain current regulatory knowledge Qualifications & Requirements:
Bachelor's degree in a scientific discipline or equivalent.
Advanced degree or Regulatory Affairs Certification is preferred.
Candidate must possess a Candidate must have at least 3 to 7 years of Regulatory experience in the pharmaceutical or biotechnology industry, with demonstrated increasing expertise and responsibility Experience working with innovator products and designing and executing creative development strategies are highly desirable Experience with regulatory submissions, including INDs, international clinical trial applications, and marketing applications in Common Technical Document format, is essential.
Candidates must be local and commutable to Mercer County, NJCandidates must be authorized to work in the US for any employerFor complete details and consideration, please apply here or email your resume to email removed and reference job number:
440851.
Estimated Salary: $20 to $28 per hour based on qualifications.
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