EMPLOYMENT
Posting No.: 64-08

POSITION AVAILABLE

TITLE: Global Head of Regulatory Affairs and Quality Assurance

REPORTING TO: General Counsel and Secretary

SALARY: Depends on qualifications and experience

LOCATION:  Dual-location position (both locations in New York, NY)

• Primary: Laboratory, Center for Biomedical Research, Weiss Research Building, Rockefeller University Campus, New York, NY
• Secondary: Population Council Headquarters, One Dag Hammarskjold Plaza, New York, NY

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

JOB DESCRIPTION

The Population Council seeks a global head of regulatory affairs and quality assurance to develop and provide leadership to the regulatory affairs and quality assurance team and to develop regulatory submission strategies on a global, regional, and country level. S/he will be responsible for ensuring the overall organizational compliance with applicable regulations pertaining to research conducted worldwide and oversee all aspects of regulatory affairs within the Population Council’s United States and overseas operations, including providing guidance to product development teams working in the Reproductive Health and HIV and AIDS programs and research staff conducting clinical and nonclinical studies, and support to the Institutional Review Board (IRB). The incumbent will manage a regulatory and quality assurance team; oversee the preparation of filings, responses, amendments, and reports; and assist in the resolution of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Management Practice (GMP) issues.

RESPONSIBILITIES

1. Develop regulatory affairs and quality assurance team and provide team leadership. Responsible for the development, retrieval, and maintenance of worldwide regulatory submissions, licenses, and certificates.
2. Oversee the preparation of regulatory documentation including, but not limited to, Chemistry, Manufacturing and Control (CMC) sections, study reports, annual reports, and Investigational New Drug Applications (IND) for new and existing products.
3. Provide guidance and training to management and staff regarding clinical trials and the implementation of GCP, GLP, and GMP in collaboration with the quality assurance/quality control (QA/QC) unit as well as supervise the quality assurance functions for the Council, including the development and maintenance of regulatory policies and procedures and standard operating procedure (SOP) administration.
4. Oversee submission of regulatory files, clarification of requests for information, responses, amendments, and reports for various products.
5. Ensure effective and appropriate communication with Regulatory Agencies (i.e., Food and Drug Administration [FDA], Department of Health and Human Services [DHHS], European Medicines Agency [EMEA], and other foreign agencies).
6. Oversee the development and implementation of reporting strategies and submission timelines.
7. Ensure the Council’s compliance with FDA and DHHS regulations for the protection of human research subjects, including oversight of administration of the IRB. Provide support to the chair and administrator of the IRB as needed.
8. Collaborate with and provide support to the Council’s research staff and medical safety expert & head of medical affairs in the reporting of adverse events (AEs) and serious adverse events (SAEs) from clinical trials, the monitoring of IND safety databases, and the implementation of the Council’s pharmacovigilance policy. Identify risks and treatment of adverse events among research participants, and propose solutions to minimize risk.
9. Collaborate with the executive director of research and development and the clinical director of microbicides on strategies for ensuring compliance with regulatory requirements; recommend “go/no go” decisions at appropriate project milestones for IND and New Drug Application (NDA) submissions as well as other regulatory documents.
10. Collaborate with and advise the general counsel on establishing monitoring systems that ensure ongoing compliance with applicable regulations, including providing interpretations of all relevant US and international regulatory and statutory materials governing the performance of research on human subjects.

QUALIFICATIONS

1. Minimum of a bachelor’s degree in a scientific discipline, such as biology, chemistry, pharmacology, pharmacy, or related field. Advanced degree preferred (MS, PhD, or MD).
2. A minimum of ten years' regulatory affairs experience, with demonstrated capacity and experience managing regulatory operations in the biotechnological/pharmaceutical industry.
3. Demonstrated expertise in writing regulatory reports and skill in submission strategies.
4. Knowledge of FDA and International Conference on Harmonisation (ICH) regulations pertaining to GCP, GLP, GMP, and AE/SAE reporting, and experience with FDA submission process.
5. Knowledge of and experience with EMEA regulations a plus.
6. Ability to take initiative, lead, negotiate, and work as part of a team.
7. Demonstrated ability to monitor and maintain project timelines.
8. Computer literacy. Experience with Microsoft Word, Excel, PowerPoint, and Reference Manager.
9. Excellent interpersonal and oral/written English-language communication skills.
10. The position may require travel to Council locations as required for appropriate oversight of research activities and confirmation of regulatory compliance.

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 #64-08 to the attention of:

Benjamin Bilbao
Recruitment Manager
Population Council
One Dag Hammarskjold Plaza
New York, NY  10017

Fax: +1 646 277 8243
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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