Regulatory Affairs Senior Manager

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 OverviewThe Sr. Manager, Regulatory Affairs plays a pivotal role in ensuring compliance with US regulatory guidelines and federal regulations governing pharmaceutical drug development at TK-CHAIN LLC.ResponsibilitiesManage all regulatory activities associated with our clients' development projects.Provide regulatory guidance and communicate regulatory...

Company Overview Lynkx Staffing LLC is a leading recruitment agency for the pharmaceutical industry. Our mission is to provide top talent to our clients and help them achieve their goals.Job Description We are seeking a highly experienced Global Director Regulatory Affairs Strategy to join our team. The ideal candidate will have a strong background in...

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...

Medical Content and Training Manager Job SummaryAscendis Pharma is seeking a seasoned Medical Content and Training Manager to join our team. As a key member of our commercial operations team, you will be responsible for leading the development and implementation of medical content and training programs across the organization.About the CompanyAscendis Pharma...

Job DescriptionTaiho Oncology, Inc. is seeking a highly skilled Regulatory Affairs Leader to join our team.As a key member of our regulatory affairs department, you will play a vital role in ensuring the successful development and approval of our oncology products.Responsibilities:Develop and execute global regulatory strategies for clinical development...

Job OverviewTk-Chain LLC seeks a seasoned Regulatory Affairs professional to lead our team in ensuring regulatory compliance and excellence in our submissions to the FDA. As a key member of our organization, you will be responsible for planning, authorizing, compiling, and submitting high-quality regulatory submissions within company timelines and in...

Job OverviewThe Director, Regulatory Affairs role at TK-CHAIN LLC is a pivotal position that requires an advanced understanding of US regulatory guidelines and federal regulations governing pharmaceutical drug development. As a key member of the team, you will integrate knowledge of these guidelines to ensure compliance in all aspects of our clients' drug...

Job Summary:Lynkx Staffing LLC is recruiting a seasoned Pharmaceutical Regulatory Affairs Executive to lead regulatory affairs efforts for a pharmaceutical company. As a key member of the organization, you will be responsible for developing and implementing regulatory strategies for drug development programs.Key Accountabilities:Develop and implement...

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 Tk-Chain LLCWe are a leading pharmaceutical company committed to delivering innovative solutions that meet the needs of our customers. Our team is dedicated to ensuring regulatory compliance and excellence in all our submissions to the FDA. We are seeking a seasoned Regulatory Affairs professional to join our team and contribute to our success.The...

Job SummaryTk-Chain LLC is seeking a Senior Regulatory Compliance Specialist to lead CMC regulatory affairs initiatives and ensure compliance with US regulatory guidelines.Key ResponsibilitiesIntegrate knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development.Collaborate with functional groups to plan, author,...

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...

Required QualificationsTo be successful in this role, you must have:An advanced degree in a life science.A minimum of 12 years of pharmaceutical industry experience, with at least 10 years in Regulatory Affairs.At least 6 years of managerial experience.Excellent written, verbal, and negotiation skills.Advanced understanding of pharmaceutical development and...

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...

Main ResponsibilitiesLead Regulatory Affairs Functional Teams (RAFTs) to provide high-quality strategic regulatory input for optimal regulatory outcomes.Develop global/regional regulatory strategies for multiple clinical development projects at all stages.Author and review regulatory documents for submission to US and/or Rest of World regulatory...

Job Overview:Lynkx Staffing LLC is seeking a skilled Director Regulatory Affairs Chemistry Manufacturing & Controls to lead global teams in developing and executing regulatory strategies for pharmaceutical companies. As a key member of the organization, you will collaborate with project team representatives to ensure compliance with regulatory requirements...

Job DescriptionTk-Chain LLC is seeking a highly skilled Regulatory Affairs professional to lead our team in ensuring regulatory compliance and excellence in our submissions to the FDA. The ideal candidate will possess excellent communication and analytical skills, as well as a deep understanding of FDA guidelines and federal regulations.About the RoleThis...

Regulatory Affairs LeadWe are seeking a seasoned Regulatory Affairs Lead to oversee CMC regulatory affairs initiatives and ensure compliance with US regulatory guidelines at Tk-Chain LLC.ResponsibilitiesDevelop and implement regulatory strategies to support pharmaceutical drug development.Collaborate with multidisciplinary teams to plan, author, and compile...

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...