Manager, Regulatory Affairs Associate
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Job Location:
Boston, NH - USA
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Overview
Responsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and international regulations/interpretations. May determine methods and procedures on some assignments and may provide guidance to other lower-level personnel.
Responsibilities
Coordinates regulatory workflow provides regulatory support to the team and tracks project timelines and budget.
Provides ongoing regulatory support to the project team members.
Under supervision compiles regulatory submissions license renewal and annual registrations to the US Food and Drug Administration (FDA) and other regulatory agencies.
Reviews and formats technical documents (pertaining to clinical chemistry manufacturing and controls and non-clinical information). This may include the preparation of outlines summaries status reports graphs charts tables and slides for distribution and communication to other departments.
Participates in assigned Regulatory Affairs initiatives aimed at improving internal Idenix standards and tracking/control systems.
Develops and maintains current regulatory knowledge and keeps abreast of regulatory procedures and changes.
Researches and analyzes regulatory information and determines acceptability of data procedures and other product-related documentation presented in support of product registration.
Direct interaction with regulatory agencies on routine matters.
Qualifications
Bachelors/Masters Degree in a scientific discipline or equivalent with a minimum 8 years of Regulatory Affairs experience.
Must have extensive experience and understanding of CMC requirements for Small Molecule drugs.
Prior experience compiling filings for FDA submissions is required with the ability to successfully manage projects to deadlines.
A working knowledge of electronic publishing and file management systems preferred.
Excellent understanding of Microsoft Windows Office Excel Project Outlook and other common PC applications.
Excellent organizational presentation and decision-making skills and analytical thinking/problem-solving/investigative skills are required.
Certified regulatory affairs professional would be desirable
Required Experience:
Manager
Key Skills
About Company
Pioneering Therapies for Cancer and Beyond – Our drug discovery platform is tailored to promote specific protein ubiquitination and subsequent proteasomal degradation of disease-causing, undruggable proteins, in essence leading to pharmacological protein knockout with high efficiency ... View more
