|
Apply online for the
Regulatory Administrator
position and advance your career in the
Clinical-Research-Organization industry today.
|
Regulatory Administrator : Population Council
|
| Job Number |
110 |
| Employee Type |
Full Time |
| Company Name |
Population Council |
| Location |
New York
New-York
10017 |
| Salary (year) |
|
| Experience |
6 to 9 Years |
| Shift |
First Shift (Morning) |
| Industry |
Clinical-Research-Organization |
| Job Type |
Research-and-Development |
| Required Degree |
Bachelors of Science |
| Relocation |
Not Required |
| Travel Requirement |
0% |
|
Population Council
View all jobs from Population Council |
|
|
|
|
| What Does Your Boss Say About You? |
| Description |
|
The Population Council is an international, nonprofit, nongovernmental institution that seeks to improve the well-being and reproductive health of current and future generations around the world and to help achieve a humane, equitable, and sustainable balance between people and resources. The Council conducts biomedical, social science, and public health research and helps build research capacities in developing countries. Established in 1952, the Council is governed by an international board of trustees. Its New York headquarters supports a global network of regional and country offices.
TITLE: Regulatory Administrator, Microbicides, HIV and AIDS Program
REPORTING TO: Global Head of Regulatory Affairs & Quality Assurance
LOCATION: Center for Biomedical Research, New York, NY
ASSIGNMENT LENGTH: Two years, renewable by mutual consent and/or availability of funding.
JOB DESCRIPTION:
The Population Council’s HIV and AIDS Program seek a Regulatory Administrator to be responsible for maintaining the HIV Microbicide program’s regulatory files and preparation of regulatory documentation for preclinical and clinical reporting. The Regulatory Administrator will work closely with the Council’s preclinical and clinical staff.
RESPONSIBILITIES:
1. Create and maintain the HIV microbicide program’s regulatory files.
2. Interface with regulatory agencies (FDA, European Medicines Agency [EMEA], and other foreign agencies). This includes clarification of requests for information and asking questions on behalf of clinical and preclinical staff responsible for compiling report content.
3. Manage the preparation of regulatory documentation (e.g. investigator’s brochure, CMC section, study reports, annual reports, and Investigational Drug Applications [IND]) for new and existing microbicide products.
4. Ensure the acceptable completion and timely submission of regulatory documentation according to FDA and ICH regulations.
5. Keep track of all work assignments for upcoming FDA and foreign regulatory submissions.
6. Develop and implement reporting strategies and submission timelines.
7. Assist clinical and laboratory staff to ensure proper documentation of clinical and laboratory procedures for regulatory purposes.
8. Supervise maintaining the database for cross-referencing the program’s activities with the regulatory submission database.
9. Perform research on FDA, and foreign regulatory agency guidelines and requirements for Investigational Drug Applications. |
|
| Requirements |
|
1. Bachelor’s degree or equivalent experience.
2. A minimum of five (5) years’ regulatory experience, biomedical science research, or pharmaceutical/medical experience.
3. Experience with drafting or writing regulatory reports.
4. Knowledge of FDA/ICH regulations; pertaining to GLP, GMP, GCP, and AE/SAE reporting, and experience with FDA submission process.
5. Knowledge and experience with EMEA regulations a plus.
6. Knowledge of HIV science, product development, and regulatory affairs process preferred.
7. Ability to take initiative and work as part of a team.
8. Demonstrated ability to monitor and maintain project timelines.
9. Computer literacy. Experience with Microsoft Word, Excel, Power Point and Refman.
10. Excellent interpersonal, oral and written communication skills. |
|
| Contact Info |
Please send resume and cover letter, referencing job 110 to:
Benjamin Bilbao, Recruitment Manager, Population Council, One Dag Hammarskjold Plaza, New York, NY 10017; Email: jobs@popcouncil.org; Fax: 646-277-8243 |
|
|
To apply for this position directly, please
Click Here. |
|
Find More Clinical-Research-Organization Jobs in the Clinical-Research-Organization industry.
|
|