Clinical Regulatory Specialist Jobs

Coordinating with administrative and research assistants and managers to coordinate

Experience authoring, assembling, and submitting IND applications

2+ years of experience in regulatory or clinical affairs.

Writing experience is required; examples to demonstrate successful writing preferred.

Ability to research, write and manipulate data through knowledgeable use of online technologies.

Author, assemble, and submit IND applications to FDA.

Applies regulatory and technical knowledge to a wide variety of complex work assignments.

Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

Knowledge of regulations and standards affecting IVDs and/or biologics

Responsible for implementing and maintaining the effectiveness of the quality system.

Supports manufacturing/operations day to day activities for change control.

Provides consultation/advice to regulatory specialist for change control and product development.

Knowledge of US regulatory reporting requirements, and financial services-related products.

10+ years of relevant experience, including 5 years of experience preparing regulatory reports.

Prior experience interacting with regulators (preferred)

Track and monitor monthly data source submissions and processing

Liaise with the Technology team to implement and test developed reporting process changes and/or investigate processing issues.

Prepare all necessary FR Y-10 Reports when reportable events occur.

Strong relationship management, analytical, and interpersonal skills required to quickly gain confidence of stakeholders and team members required.

Strong organizational skills enabling the management of multiple, simultaneous submissions often with different team members and different timelines.

Formal project management training optimal; practical project management skills and recent application required.

Manages communications and activities with third-party publishers and regulatory vendors.

Manages and indexes archives of regulatory submissions; manages and files regulatory correspondence.

Familiarity with Veeva Vault – RIM, Sharepoint, and publishing software strongly preferred. Sophisticated MS-Office skills required.

Working knowledge of industry and regulatory requirements

Act as lead project manager for Regulatory projects

5-7 years’ minimum experience in FDA, USDA, and/or TTB Compliance

Knowledge of beverage industry terms and processes

Attention to detail and organizational skills

Strong critical thinking and problem-solving skills

Ensures the Quality Management System (QMS) is up to date per regulatory and sponsor requirements and maintains assessment/audit processes and documentation

Quality Management System/Regulatory Compliance Program

Regulatory certification from AAAHRP, SOCRA, PRIM&R or similar organizations

Has GCP training and follows GCP guidelines and other guidelines related to the conduct of human subject’s research

Develops and maintains departmental and study level SOPs in relation to clinical trials and according to FDA regulations and GCP guidance

Coordinates review, approval, and dissemination of policies with the internal compliance committee

Familiarity with medical device requirements in the US and/or EU (Class III experience is a plus)

Review QMS and product changes for compliance to regulatory requirements

Ensure compliance with corporate and regulatory requirements (e.g., GCP and ISO 14155).

Knowledge of medical device US and EU regulations, standards, and guidance documents (21 CFR 820, MDR, ISO 13585, ISO 14971, etc.)

2+ years previous experience in medical device product development or related field. Regulatory affairs, clinical affairs, or clinical research experience required.

Must be able to manage or support multiple projects.

Demonstrated ability to organize, track, and prioritize work responsibilities and regulatory deadlines.

Bachelor’s Degree or significant work experience in research or academic research administration preferred.

As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices

Provides researchers information regarding the status of registrations; expiration dates, continuing review, committee deadlines and meeting dates.

Must be competent in the use of computers including Microsoft Excel, Word, PowerPoint, Access and email internet programs.

Org Unit: Environmental Health & Safety