Regulatory Affairs Specialist

**Job Title:** Regulatory Affairs Manager**Location:** Pine Brook, New JerseyAt TK-CHAIN LLC, we are seeking an experienced Regulatory Affairs Manager to lead our regulatory activities associated with planning, authorizing, compiling and submitting highest-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory...

Job OverviewTK-CHAIN LLC seeks an experienced Regulatory Affairs Senior Manager to lead our regulatory submissions team. Reporting directly to the Director/Associate Director Regulatory Affairs, this role will be based in Pine Brook, New Jersey.In this challenging and dynamic position, you will oversee the planning, authoring, compiling, and submitting...

Job Title: Senior RA ManagerWe are seeking an experienced individual for the role of Senior Regulatory Affairs Manager. The ideal candidate will have a strong background in regulatory affairs within the pharmaceutical or biotech industries.The estimated salary for this position is $120,000 - $150,000 per year, depending on experience.Key...

Job SummaryWe are seeking a highly skilled Senior Associate Regulatory Operations CMC to join our team at TK-CHAIN LLC. The successful candidate will have a minimum of 5 years of experience in the pharmaceutical industry with 3-4 years in regulatory affairs.About the RoleThis is a challenging and rewarding role that requires exceptional attention to detail,...

Job OverviewThe Chief Regulatory Affairs Strategist plays a pivotal role in TK-CHAIN LLC drug development programs, ensuring compliance with US regulatory guidelines and federal regulations.This position is responsible for integrating knowledge of pharmaceutical drug development into all aspects of the company's drug development policies and procedures,...

About the JobWe are seeking an experienced Regulatory Labeling Associate to join our team at TK-CHAIN LLC. The successful candidate will be responsible for preparing, reviewing, and submitting high-quality regulatory labeling submissions to the FDA.This is a dynamic role that requires strong analytical and problem-solving skills, as well as excellent...

About Us:TK-CHAIN LLC is a pioneering pharmaceutical company committed to delivering innovative solutions that meet the evolving needs of patients and healthcare professionals. As a Senior Manager, Regulatory Affairs, you will play a vital role in shaping our regulatory strategy and ensuring compliance with regulatory requirements.">Job Summary:We are...

Job Title:Senior Regulatory Content SpecialistOverviewWe are seeking a Senior Regulatory Content Specialist to provide strategic leadership and subject matter expertise in the development of clinical regulatory documents. The ideal candidate will have a strong background in medical writing, regulatory affairs, and experience working with cross-functional...

Gardner Resources Consulting, LLC is seeking a skilled Pharmaceutical Regulatory Affairs Expert to join our team. As a regulatory affairs expert, you will play a key role in ensuring compliance with US pharmaceutical industry and healthcare landscape guidelines.Estimated Salary: $120,000 per yearAbout the Job:This position requires a thorough understanding...

About the JobSPECTRAFORCE invites applications for a Regulatory Affairs Quality Associate - Clinical Research. As a key member of our team, you will contribute to the development and implementation of quality systems that ensure compliance with regulatory requirements.The estimated annual salary for this role is $90,000 - $120,000.ResponsibilitiesMain...

Job Title: Associate II Regulatory LabelingThe TK-CHAIN LLC is seeking a highly motivated and detail-oriented individual to join our team as an Associate II Regulatory Labeling. This role plays a critical part in ensuring the accuracy and compliance of our pharmaceutical products' labeling submissions to the FDA.About the Role:In this position, you will be...

TK-CHAIN LLC is a dynamic and innovative company that is looking for a highly skilled Compliance and Regulatory Strategy Lead to join our team in Pine Brook, New Jersey.The estimated salary for this role is $140,000 - $200,000 per year, based on industry standards and the candidate's qualifications.Job DescriptionWe are seeking a seasoned regulatory...

Are you an experienced regulatory professional looking for a challenging role in the pharmaceutical industry? Look no further! TK-CHAIN LLC is seeking a highly skilled Director of Pharmaceutical Regulatory Compliance to join our team in Pine Brook, New Jersey.The estimated salary for this role is $130,000 - $190,000 per year, based on industry standards and...

About TK-CHAIN LLCWe are seeking a highly skilled Director, Regulatory Affairs to join our team at TK-CHAIN LLC. This individual will be responsible for integrating knowledge of pharmaceutical drug development into all aspects of our company's drug development policies and procedures.The annual salary for this position is approximately $195,000, based on...

Are you a seasoned professional looking for a new challenge? We are seeking a highly skilled Regulatory Affairs Chemistry Manufacturing & Controls Director to join our team at Lynkx Staffing LLC. In this role, you will develop and execute regulatory strategies for CMC components, oversee all RA-CMC operations, and mentor junior colleagues in lifecycle...

Company OverviewTK-CHAIN LLC is a leading provider of innovative solutions in the pharmaceutical industry. We are committed to excellence and innovation, and we seek individuals who share our passion and values.About the JobThe Senior Associate Regulatory Operations CMC will play a critical role in ensuring the quality and compliance of our regulatory...

Job ResponsibilitiesThe successful candidate for the Director of Regulatory Compliance role will be responsible for overseeing the management of regulatory activities associated with planning, authoring, compiling, and submitting high-quality regulatory submissions to the FDA. This includes preparing and compiling new ANDAs, Amendments, Supplements, Annual...

About the RoleWe are seeking a highly motivated Manager Regulatory Submissions to join our team in Pine Brook, New Jersey. In this critical role, you will manage the preparation and compilation of new ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2), and 505(b)(1) filings, ensuring they meet applicable regulatory guidelines and the highest quality...

TK-CHAIN LLC is seeking an experienced Head of US Regulatory Strategy to join our team in Pine Brook, New Jersey. This role requires a minimum of 12 years of pharmaceutical industry experience, with at least 10 years in Regulatory Affairs and 6 years of managerial experience.You will be responsible for leading cross-functional teams to develop and implement...

About the JobLynkx Staffing LLC specializes in placing professionals in the Biotechnology, Pharmaceutical, and Medical Devices industries in New Jersey. We are seeking a talented Global Director Regulatory Affairs Strategy to join our team.The ideal candidate will have a Ph.D. or PharmD degree, 5-10 years of Regulatory Affairs experience, and strong...