Senior Regulatory Affairs Manager

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...

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 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:** 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...

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 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...

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,...

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...

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...

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 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...

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 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...

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...

Transforming Lives through Innovative Cell TherapyBristol Myers Squibb is a company that pushes boundaries and breaks through barriers in the field of cell therapy. We are seeking a highly skilled and experienced professional to lead our medical project management teams and drive strategic planning for our Worldwide Medical Affairs Cell Therapy...

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 Summary:We are seeking a Medical Affairs Strategist to support the UroGen team in communicating scientific, clinical, and technical information through strong collaborative relationships with internal and external stakeholders.The ideal candidate will provide operational and strategic support to execute Medical Affairs goals and objectives.Main...