Clinical Regulatory Specialist Jobs

Our client is a leading independent management consulting firm focused on the global financial services industry.

They are looking for a

P.S - This is a hybrid opportunity based out at Midtown, NY.

Work in close collaboration with our corporate regulatory, commercial, operations, and purchasing teams to comply with OSHA requirements

Assist in the implementation and continuous improvement of Responsible Distribution certification, including training, internal audits, and certification audits.

Other duties and responsibilities as requested

Previous experience (3+ years) in a regulatory/compliance role considered a plus

Strong problem solving, organizational skills, attention to detail, and communication skills

Strong interpersonal skills and ability to communicate effectively throughout the organization

2-5 Years Proven Project Management Experience.2-5 years experience with a federal government agency is preferred.

Effective and confirmed negotiation skills and have the ability to influence decisions and others.

Handle and support critical issues from regulators and monitoring authorities, media, and non-government organizations from around the world.

Support managing and further developing the eBay Regulatory Portal.

Be proficient with eBay’s customer service tools.

Conduct investigations and analysis of non-compliant/potentially criminal conduct.

Outstanding customer-focused and account management skills.

Become an expert at understanding the Healthcare Partner’s unmet needs related to the management and protection of closed surgical incisions.

Effectively communicate the clinical, ease-of-use and cost-savings benefits of NPseal® compared to traditional dressings and NPWT competitive offerings.

Develop and manage relationships with Key Customer decision-makers including Physicians, Nurses, decision makers, and Operating Room staff.

Manage travel and expenses per approved budget and timelines.

Other responsibilities as necessary to perform position.

Interest in data and information management.

Bachelor’s degree with 3 years of relevant experience.

Strong written and oral communication skills

Experience with information security programs (e.g., Controlled Unclassified Information, Privacy, etc.)

Experience independently developing technical documents and research papers.

Experience developing and delivering presentations for senior leadership.

Crisis Management: Assist in handling product-related crises or recalls, coordinating efforts to address safety concerns and regulatory issues promptly.

Bachelor's degree in a relevant field, such as Regulatory Affairs, Product Management, or a related discipline.

Product Documentation: Manage and organize product documentation, including specifications, testing reports, and certificates, to support compliance efforts.

Labeling and Packaging: Review and approve product labeling, packaging materials, and marketing materials to ensure they adhere to regulatory requirements.

Knowledge of relevant regulations and standards in the industry, with a strong focus on product safety and compliance.

Strong attention to detail and organizational skills.

Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.

Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical research/clinical trials.

May provide training and education to other personnel.

Participates in required training and education programs.

Five (5) years minimum of directly related experience; 2 years of regulatory experience and 3 years of clinical research experience.

Ability to identify areas of project interest and connect with appropriate support group: CCTO SPIN, IRB, Tech Transfer

Perform administrative and data entry job functions, including analyzing and interpreting Microsoft Excel data and database management.

At least 2 years of experience working in a customer service, administrative assistant, or data entry-driven role

Spanish foreign language skills required

Strong problem-solving and critical thinking skills.

Solid organizational skills with the capability to support multiple simultaneous projects.

Strong technical (system) and computer skills with proficiency in Microsoft applications (e.g., Word, Excel, PowerPoint, etc.).

-Exceptional communication, analytical, presentation and time management skills

-Excellent working knowledge of regulatory compliance requirements and procedures

-Ability to demonstrate impact on project goals through proactive solutions and keeps management aware of project schedules/timelines.

-Knowledge of MS Office suites, database, spreadsheets, graphic and communications applications

-Extensive knowledge of oncology clinical trials and oncology terminology required.

Manage a steady stream of projects, including the preparation and development of approved packaging production artwork.

Follow defined processes and documentation to ensure the highest quality and compliance to cGMP and FDA requirements.

Bachelor's degree in Graphic Design, Packaging, New Media, Printing, or equivalent experience.

In-depth knowledge of Adobe Illustrator and InDesign.

Understanding of GMP requirements in a regulated environment is a plus.

Oversee the artwork approval process, collaborating with Regulatory, Marketing, Legal, Engineering, Quality, and Supply Chain teams.

Proficient in Microsoft Word, EndNote, Adobe Acrobat, Acrobat Plug-ins, Document Management Systems, Excel, StartingPoint templates

Manage the regulatory activities log tracking annual and current submissions

Direct publishing experience a plus

Knowledge of the regulatory archival, records and submissions systems with demonstrated ability to learn new systems and processes.

Experience in preparing INDs, CTAs, NDAs, BLAs and MAAs

Excellent writing skills (e.g., English usage), a keen attention to detail, and strong verbal and interpersonal communication skills

Review Environmental Protection Plans, Waste Management Plans, SPCC Plans and other similar work products for the benefit of DoD projects.

Assist in the establishment and management of DOD regulatory submittal quality assurance programs within the Marianas Islands.

Certifications, License And Physical Requirements

Perform expediter work as mutually agreed upon between the Joint Region Marianas and the EPA to directly benefit DoD priorities.

Review and identify technical problems and situations to assist government personnel in responding to and resolving requirement comments, questions and discrepancies.

Have a minimum of five (5) years' engineering experience; more environmental engineering experience is highly desirable.

Effective time management and organizational abilities

Input all regulatory inquiries into the appropriate compliance or risk management system

Experience in computer skills including Excel

Develop education to address immediate and long term issues

Education: Minimum Associates degree, Bachelor’s degree preferred

Knowledge of state and federal rules and regulations a plus

May participate in continuous improvement activities related to role including supplier payment management, external agreement process, etc.

Arranges event planning for internal meetings and Kaizen events, including ordering supplies, coordinating meals, arranging hotel room blocks, etc.

Maintains organizational charts for both departments and maintain email distribution lists.

Supports expense reporting for leadership in GRA and GCA.

Title: Global Clinical & Regulatory Affairs Operations Coordinator

8:00 AM - 5:00 PM EST (includes one hour lunch)

5-10 years of clinical trial regulatory management experience.

Quality Management System/Regulatory Compliance Program

5 Years minimum regulatory experience in clinical trials

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

Experience gained from multiple perspectives: industry sponsor, CRO, academic, government or site level

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

Maintain knowledge of current regulatory requirements and standards, and communicate changes to relevant stakeholders.

Knowledge of FDA regulations and international regulatory requirements.

Hybrid Work Environment: 3 days onsite, 2 days work from home

4+ years of experience in regulatory affairs within the medical industry.

Experience with registration and commercialization of medical devices.

Strong analytical, problem-solving, and decision-making skills.

Bachelor's Degree and 3-5 years of relevant experience or equivalent combination of education and experience.

Knowledge and experience with FDA Clinical Trial regulations and guidance.

3 years of relevant experience in an academic regulatory environment.

Experience with IND/IDE/Clinical Trial Application.

Process initial regulatory documents for submission to Pharmaceutical Sponsors and Institutional Review Board (IRB).

Prepare and process regulatory documentation through IRB, CTSRMC, FDA, and other regulatory review committees.

Complete all other duties as assigned by management.

Strong interpersonal and communications skills and organizational and planning abilities needed to handle multiple tasks concurrently.

Research of International, Federal, State, local, and internal regulatory requirements

Maintain working knowledge and understanding of existing and emerging food and dietary supplement regulations.

Assisting with obtaining, and/or renewing relevant national certifications.

Work closely with the Quality Manager and Product Development teams to ensure compliance.

3+ years of experience working in agricultural biotechnology and/or phytosanitary regulatory or similar

BS in biology, crop science, plant pathology, agricultural business, or related field, graduate degree preferred, or equivalent experience

Knowledge of APHIS administrative procedures and regulations

Experience interacting with state, federal, or international regulators (preferred)

Comprehensive Benefits Plan, including Medical, Dental, Vision, HSA/FSA, 401k, Life Insurance, Short-Term & Long-Term Disability, and more!

🌎 Location: U.S Remote (Some Travel)

Experience in clinical trials operations, knowledge of clinical trials regulatory requirements, or experience working with an IRB.

Knowledge, Skills And Abilities (required)

Bachelor’s degree and three years of related experience or a combination of education and relevant experience.

Manage and oversee new study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support.

Excellent communication skills and superb attention to detail.

Experience with MS Office products and database applications required.