Head of US Regulatory Strategy

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...

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...

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...

Lead the Way in Biometric Data SciencesWe are seeking a skilled biostatistician to join our team as the Head of Global Biometric Data Sciences at Bristol-Myers Squibb. As a member of our leadership team, you will play a critical role in driving innovation and excellence in biometric data sciences.About the OpportunityThis is an exceptional opportunity to...

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: 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...

Otsuka seeks a Senior Director, Diversity and Inclusion Strategy to join its Talent Management Leadership team. This key role will drive the advancement of diversity & inclusion's vision in partnership with the Head of Talent Management and other senior stakeholders.Key Responsibilities:The Senior Director will work closely with the head of Talent in driving...

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...

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...

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 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...

About the RoleThis is an exciting opportunity to join a talented team of biometric professionals at Bristol Myers Squibb. As the Head of Global Statistical Development, you will be responsible for overseeing the development and execution of global biometrics strategies, driving scientific excellence and accelerated drug development.What You'll Do:Develop and...

ResponsibilitiesDevelop and implement a regulatory document strategy to support our clinical development programsCreate high-quality clinical documents, including protocols, clinical study reports, and investigator brochuresCollaborate with cross-functional teams to ensure document accuracy and complianceManage competing priorities and deadlines to deliver...

TITLE: Associate, Regulatory LabelingOVERVIEW OF THE COMPANYTK-CHAIN LLC is a dynamic company that values innovation and excellence in the pharmaceutical industry.We are committed to delivering high-quality products and services that meet the evolving needs of our customers.SALARY: $85,000 - $110,000 per yearJOB DESCRIPTIONThe Associate, Regulatory Labeling...

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 UsBristol-Myers Squibb Company is a global biopharmaceutical company that is dedicated to transforming patients' lives through science. Our mission is to be an innovative leader in the pharmaceutical industry, with a commitment to advancing medical science and improving patient outcomes.Job SummaryWe are seeking an experienced Safety Assessment...

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...

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...

Compensation and BenefitsWe offer a competitive salary range of $32.56 - $45.48 per hour, depending on experience, as well as a comprehensive benefits package, including health insurance, an incentive and recognition program, and 401K contribution.Why Work with Us?Opportunity to work with a leading medical device company in the Princeton, NJ area.Competitive...

TITLE: Associate, Regulatory LabelingROLE RESPONSIBILITIESThe Associate, Regulatory Labeling will be responsible for preparing, reviewing, and submitting regulatory labeling submissions to the FDA.This includes preparing responses to labeling comments received from the US FDA and serving as the PRC Chair to review and approve advertising and promotional...