JOB TITLE: Senior Manager, Regulatory Affairs
REPORTING TO: Global Head, Regulatory Affairs & Quality Assurance
LOCATION: Center for Biomedical Research, New York, NY
JOBS SUPERVISED: N/A
ASSIGNMENT LENGTH: 2 years renewable by mutual consent and availability of funding
POSITION SUMMARY: S/he will ensure successful regulatory submissions to the appropriate regulatory agencies regarding the Council’s clinical products. S/he must see to the provision of accurate and appropriate regulatory documentation, and ensure that the Council’s clinical trial operations and procedures comply with all relevant FDA regulations. In addition, the Senior Manager, Regulatory Affairs will track and keep the appropriate records and conduct DEA audit document preparation, thereby ensuring the safe shipping of drug products and controlled substances.
U.S. Food and Drug Administration (FDA)
Chemistry, Manufacturing, and Controls(CMC)
Drug Enforcement Administration (DEA)
Investigational New Drug (IND) European Medicines Agency (EMA)
1. Under the direction of the Head of Regulatory Affairs and with the assistance of the project team, this position recommends and implements programs and procedures that will produce clear and successful strategies with regard to providing submissions to the appropriate and necessary regulatory agencies, thereby assuring successful regulatory submissions. This is accomplished by conducting such actions as:
a. developing and institutionalizing the necessary steps and pathways that will assure successful regulatory submissions,
b. providing summaries of all the needed elements relating to strategizing for submissions,
c. directly preparing and assembling the specific facets of submissions to the FDA and health authorities such as annual reports, amendments (protocol, clinical, nonclinical, and CMC), and supplements,
d. providing direction to other departments regarding their respective contributions, and the synchronization of those contributions with respect to the timelines of the submission for the required agencies, and the development of specific reporting timelines, and
f. establishing and then developing direct and efficient lines of communication (“hot-lines”) with FDA, EMA, and regulatory departments and contacts within partnering organizations and companies, regarding product development, respective timelines, and agency guidelines; thereby addressing the criticality and sensitivity of such communications.
2. Ensure the existence and availability of accurate and appropriate regulatory documentation for new and existing microbicide products, by managing the preparation and publishing of such documents as investigator’s brochures, CMC section, study reports, annual reports, and IND’s. The incumbent will assist in setting timelines, and assigning responsibilities to contributing team members (eg. Statistics, Clinical, Data Management) and follow up on assigned tasks, while reviewing contributing documents.
3. Ensure FDA regualatory compliance relating to the running and operations surrounding the Council’s clinical trials, by preparing selected regulatory documents relating to clinical trial operations, and making sure that the Council’s clincal trial staff members have obtained such mandated forms as financial disclosure forms and other required agency documentation forms.
4. Provide oversight with regard to the regulatory requirements, compliance, the tracking, and record keeping of shipments of investigational drug products and controlled substances to clinical sites for clinical studies by:
a. establishing proper timelines and distribution policies (in concert with the clinical team), and
b. preparing auditable documentation for the DEA regarding shipment(s) and use of controlled substances.
1. Bachelor’s degree or equivalent experience. Advanced degree and/or Regulatory Affairs Certification preferred
2. Minimum of seven (7) years experience working in an FDA regulated environment . Must include cGMP, however expanded cGxP experience is desirable.
3. Must be able to travel domestically.
4. Supervisory experience, desirable.
5. Must have strong technical writing skills. Must be able to summarize technical documents in a manner easily explainable to regulatory agencies.
6. Strong communication skills; oral/written and listening.
7. Strong computer skills.
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 country offices. We are seeking an individual to fill the position described. If you know of a qualified candidate or are interested in this position, please apply at: http://www.popcouncil.org/employment/index.asp .
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 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.
Population Council - 21 months ago