Compliance and Regulatory Strategy Lead

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...

Key ResponsibilitiesLead/support cross-functional teams to ensure strategic regulatory input is provided for optimal regulatory outcomes and product value.Develop and create global/regional regulatory strategies for multiple clinical development projects at all stages.Author/review regulatory documents for submission to US/Rest of World regulatory agencies...

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...

Job Description:We are seeking a highly experienced Regulatory Affairs Chemistry Manufacturing & Controls Director to join our client's team. As a key member of the organization, you will be responsible for leading global teams in developing and executing regulatory strategies for pharmaceutical companies.Key Responsibilities:Plan, prepare, and critically...

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...

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...

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 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,...

Grove Technical Resources, INC is a dynamic and growing organization, and we are seeking a talented individual to fill the position of CAPA Process Lead. As a key member of our quality team, you will play a critical role in maintaining and improving our quality management system by ensuring effective resolution of quality issues and compliance with...

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 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...

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...

MSCCN is seeking a Regulatory Compliance Coordinator to join our team in Princeton, NJ. This role offers a competitive salary range of $40.00 to $45.30 per hour.As a Regulatory Compliance Coordinator at MSCCN, you will be responsible for ensuring that all documents and records are maintained in accordance with FDA regulations and ISO standards. Your duties...

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 Requirements To be successful in this role, you will need:Education and Experience: Ph.D. or PharmD degree5-10 years Regulatory Affairs experienceStrong experience in Regulatory StrategyMust have led or currently leading an NDA or BLA filingMust have led or currently leading the strategy and authoring of a study plan, i.e., pediatric study, etc.Must have...

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 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...

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...

Job Description:We are seeking a Strategic Brand Development Manager to support our pharmaceutical portfolio. In this role, you will play a critical leadership position on accounts guiding both clients and internal teams. We're looking for someone with a strong pharmaceutical and healthcare marketing background to both HCPs and consumers, a positive...

Job OverviewUroGen seeks a highly experienced Principal Medical Writer to lead the development of clinical regulatory documents. As a key member of our team, you will drive the efficient creation of high-quality study-level and program-level documents.Salary: $150,000-$170,000 per yearResponsibilitiesResearch, write, and edit complex clinical and...