Regulatory Affairs Associate Jobs

1000+ jobs

PURPOSE - Ensure regulatory compliance with all nutrition labels, and claims made on shipping materials, advertising and promotions. PRINCIPAL ACCOUNTABILITIES – Develop nutrition facts panels and ingredient information for all new and reformulated products, including products being launched internationally. Submit products for analytical testing and maintain nutrition database. Ensure regulat...

SUMMARY This position will act as a Regulatory Affairs / Quality Assurance associate in the QA Department at Medstrat, Inc in Downers Grove, IL. It is focused primarily on assisting with international regulatory activities for establishing new markets, and maintaining device listings with the FDA. Additionally, the position supports QA responsibilities for device verification, for maintaining com...

Job ID 166255BR Posting Title Associate Director, Regulatory Affairs (Clinical Development) Division Influenza Business Unit FLU GL DEVELOPMENT Country USA Work Location Holly Springs, NC Company/Legal Entity USA Novartis Vaccines and Diagnostics, Inc. Holly Springs, NC Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description Job Purpose: Manages...

GENERAL STATEMENT OF DUTIES (Overview of job responsibilities): Provide hands-on support with respect to overall corporate/supplier compliance to FDA and other governmental regulatory requirements in medical devices. ESSENTIAL DUTIES AND RESPONSIBILITIES (Detailed list of duties) Ensure that all Drive facilities are in full compliance with the FDA and other federal and state regulations, includ...

Description: Position Description: Bring us your experience, your head for strategy, your strength with relationships and your eye for opportunity. In return we offer an unmatched place to grow and develop your career among a richly diverse group of businesses driven by the power and stability of a leading health care organization. Come help us heal and strengthen the health care system as you d...

Job ID 159897BR Posting Title Global Program Regulatory Affairs Manager / Associate Director Division PHARMA Business Unit ONCOLOGY BU - NPH Country USA Work Location Cambridge, MA Company/Legal Entity NIBRI Functional Area Research & Development Therapeutic/Disease Area Oncology Job Type Full Time Employment Type Regular Job Description The Global Program Regulatory Affairs Manager / A...

Job ID 162327BR Posting Title Associate Director, Regulatory Affairs Division Influenza Business Unit FLU GL DEVELOPMENT Country USA Work Location Cambridge, MA Company/Legal Entity NOVARTIS VACCINES & DIGNOSTICS Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description Job Purpose: Manages all regulatory interactions with local health authorities...

Job ID 162979BR Posting Title Associate III, Regulatory Affairs Division SANDOZ Business Unit COMMERCIAL OPERATIONS, NORTH AMERICA Country USA Work Location Princeton, NJ Company/Legal Entity Sandoz Inc Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description Job Purpose Prepare, review and submit regulatory filings in support of BD&L, Due Dilige...

Job ID 165438BR Posting Title Associate II, Regulatory Affairs Division SANDOZ Business Unit COMMERCIAL OPERATIONS, NORTH AMERICA Country USA Work Location Princeton, NJ Company/Legal Entity Sandoz Inc Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description Job Purpose To publish, review, and deliver technically compliant quality eCTD submission...

Regulatory Affairs Associate (Pharma Submissions) We create innovative ways to help our customers improve patient care. We rely on bold and inspired employees who share our commitment to helping solve some of healthcare's most critical challenges. Our client is a global medical technology company focused on addressing many of the world’s most pressing and evolving health needs. With our combined...

A global cosmetics and wellness company is seeking an experienced Regulatory professional to work in their US headquarters, located in Orange County, CA: Experience Required: Minimum 5 years Regulatory Affairs Experience Working knowledge of the current regulations and guidances for the U.S. and Asian Markets Good computer skills are necessary Strong written and oral communication skills Edu...

Company: Takeda Pharmaceuticals, Cambridge MA Type: Full-time, Permanent ACCOUNTABILITIES: - Oversees as well as executes all regulatory activities of multiple projects including one highly complex project in development and/or supports regulatory activities for assigned marketed product(s) of responsibility. - Manages direct reports to support scope of project work. - Provides a regulatory s...

Senior Manager or Associate Director, Regulatory Affairs Biological New Projects-00511488-39799 Description Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,600 people and operates in more than 150 countries worldwide. Merial ...

Kelly Clinical Research has an exciting opportunity for a Regulatory Affairs Temp. This is a 6 month contract opportunity with the potential to extend in Mansfield, MA at a medical device company. The Regulatory Affairs Temp will coordinate activities for a variety of device regulatory approvals in association with company rebranding including: database management, labeling reviews, export certifi...

Associate Vice President Regulatory Affairs-00470272-56561 Description Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus ...

Associate Principal, Regulatory Affairs - CMC Biologics-00473049-39181 Description enzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. ...

Associate Principal, Regulatory Affairs - CMC Biologics-00474883-39105 Description Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees....

This is an excellent opportunity to be an Associate Director Regulatory Affairs with a publicly traded pharmaceutical company in White Plains, NY. You will be responsible for managing Regulatory Affairs activities (nonclinical and clinical) for investigational and/or marketed products, including development of regulatory strategies for investigational drugs and post-approval marketed product suppo...

Clinical Regulatory Affairs Senior Associate Responsible for the compilation and completion of required regulatory filings. Provide regulatory support to client as required Provide assistance to ARD for invitro BE studies as needed Support FDA Congressional Policy Committer comment compilation and submission Develop Departmental SOP Assist with ANDA as required · 3+ years regulatory affairs ...

Regulatory Affairs Associate Duties: Coordinate the preparation and submission of domestic and international regulatory submission, ensuring submission are of high quality and comply with applicable regulations and guidelines. Manage generation and submission of Annual Reports on time and in compliance with applicable regulations. Attend relevant functional area and project team meetings, incl...