EMPLOYMENT
Posting No.: 38-08

POSITION AVAILABLE

TITLE: Regulatory Administrator, Microbicides, HIV and AIDS Program

STARTING SALARY: Depends on qualifications and experience

LOCATION: Center for Biomedical Research, New York, NY

ASSIGNMENT LENGTH: Two years, renewable by mutual consent and funding availability

JOB DESCRIPTION

The Population Council’s HIV and AIDS program seeks a regulatory administrator to be responsible for maintaining the HIV microbicide program’s regulatory file and preparing 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 (US Food and Drug Administration [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. Ensure the acceptable completion and timely submission of regulatory documentation according to FDA and ICH regulations.
4. Manage the preparation of regulatory documentation (e.g., investigator’s brochure, Chemistry, Manufacturing, and Controls section, study reports, annual reports, and Investigational New Drug Applications) for new and existing microbicide products.
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 New Drug Applications.

QUALIFICATIONS

1. Bachelor’s degree or equivalent experience.
2. A minimum of five years’ regulatory, biomedical science research, or  pharmaceutical/medical experience.
3. Experience with drafting or writing regulatory reports.
4. Knowledge of FDA/ICH regulations pertaining to Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice, and adverse event/serious adverse event 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, and PowerPoint and Reference Manager.
10. Excellent interpersonal, oral and written communication skills.

APPLICATIONS

The Population Council is an international, nonprofit, nongovernmental organization 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. We are seeking an individual to fill the position described. If you know of a qualified candidate or are interested in applying for this position, please send resume and cover letter referencing Job #38-08 to the attention of:

Human Resources Specialist
Population Council
Center for Biomedical Research
1230 York Avenue
New York, NY 10065

Fax: +1 212 327 7678
E-mail: jobs@popcouncil.org

The Population Council provides equal opportunity; it does not discriminate against any person with regard to age, color, creed, national origin, disability, political belief, veteran status, religion, marital status, gender, gender identity, or sexual orientation. Decisions on employment are based on an individual’s qualifications as related to the position for which s/he is being considered. The Council has an affirmative action program and especially encourages applications from qualified women and members of minority groups. The Population Council is international in the composition of its board of trustees and its staff, as well as in the nature and deployment of its activities.

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This page updated 30 June 2008

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