Regulatory Affairs Manager for Pharmaceutical Development

6 days ago

Princeton, New Jersey, United States TK-CHAIN LLC Full time
Job Description

The Sr. Manager, Regulatory Affairs plays a crucial role in integrating and applying knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of TK-CHAIN LLC's drug development programs, policies, and procedures; ensuring a compliant state of regulatory commitment.

This position ensures that appropriate CMC regulatory activities occur in support of both pre and post-approval submissions while meeting aggressive timelines and adhering to the highest quality standards. The successful candidate will work on increasingly complex projects/problems where analysis of the situation or data requires evaluation of some intangible factors.

In this role, you will collaborate with functional groups to plan, author, compile, and submit high-quality original applications, amendments, supplements, and responses to inquiries from the FDA.

Responsibilities:
1. Manages all regulatory activities associated with TK-CHAIN LLC's development projects, as assigned.
2. Participates in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals for assigned projects.
3. Provides guidance to multidisciplinary teams on the content, format, style, and architecture of US submissions for assigned submissions.
4. Critically reviews documentation intended for submission to the FDA for internal consistency, for consistency to relevant FDA guidelines, and to promote regulatory excellence.
5. Manages the organization, preparation, and review of new ANDAs, amendments, supplements, annual reports, and other regulatory documents and correspondence, as assigned.
6. Performs and manages critical analyses of data and independently develops interpretations and conclusions for discussion/consideration with regulatory management.
7. Ensures the completeness and accuracy of all assigned regulatory submissions.
8. Responsible for the planning, preparation, and submission of regulatory documentation according to planned timing.

Qualifications:
An advanced degree in a life science is required, along with a minimum of 10 years of pharmaceutical industry experience, at least 8+ years in Regulatory Affairs with an emphasis on CMC. The ideal candidate must have managerial experience.
They should exhibit excellent written, verbal, and negotiation skills and be able to effectively articulate complex project-related matters.
A strong understanding of pharmaceutical development and CMC regulatory affairs, including regulatory guidelines, federal regulations, and legal considerations, is essential. Additionally, the ability to prioritize, multitask, and work in a fast-paced and dynamic environment is crucial.
A highly organized and self-motivated individual with demonstrated successes at developing fully functional regulatory teams is preferred.
The estimated salary for this position is $140,000 - $160,000 per year, depending on experience.

  • Pharmaceutical Regulatory Affairs Expert

    2 days ago

    Princeton, New Jersey, United States Gardner Resources Consulting, LLC Full time

    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...

  • Regulatory Operations Expert

    7 days ago

    Princeton, New Jersey, United States TK-CHAIN LLC Full time

    Job Summary:">This position is responsible for overseeing the assembly and publishing of regulatory documents, ensuring adherence to FDA standards and internal requirements. The ideal candidate will have excellent communication skills, in-depth knowledge of FDA guidelines, and a strong critical thinking ability.">About TK-CHAIN LLC:">TK-CHAIN LLC is a...

  • Regulatory Operations Specialist

    6 days ago

    Princeton, New Jersey, United States TK-CHAIN LLC Full time

    Job Description:At TK-CHAIN LLC, we are seeking a highly skilled Regulatory Operations Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for overseeing and managing the assembly and publishing of all documents while maintaining adherence to FDA standards and internal requirements.Responsibilities:Coordinate...

  • Pharmaceutical Campaign Manager

    7 days ago

    Princeton, New Jersey, United States KPG99 INC Full time

    Job OverviewKPG99 INC is seeking an experienced Pharmaceutical Campaign Manager to join our team. This individual will be responsible for managing complex pharmaceutical campaigns, ensuring compliance with regulatory requirements, and driving business results.The ideal candidate will have a strong background in project management, experience working with...

  • Regulatory Affairs Quality Associate

    5 days ago

    Princeton, New Jersey, United States SPECTRAFORCE Full time

    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...

  • Senior Counsel, Regulatory Affairs

    7 days ago

    Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time

    Bristol Myers Squibb is a leading biopharmaceutical company committed to transforming patients' lives through science. We are seeking an experienced Senior Counsel, Regulatory Law to join our team.As a Senior Counsel, you will play a critical role in providing legal support to various stakeholders within Global Medical, Global Commercialization Excellence,...

  • Global Communications Manager for Pharmaceutical Innovations

    7 days ago

    Princeton, New Jersey, United States Kyowa Kirin, Inc. Full time

    **Company Overview:**Kyowa Kirin, Inc. is a renowned global specialty pharmaceutical company that leverages cutting-edge biotechnologies to develop novel medicines in four key areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.We are a Japan-based organization with a strong presence in North America, where we strive to...

  • Global Regulatory Lead for Biologics

    1 week ago

    Princeton, New Jersey, United States Bristol Myers Squibb Full time

    Unlock New Horizons in Pharmaceutical DevelopmentAre you ready to take your career to the next level in a dynamic and innovative environment?Bristol Myers Squibb is seeking a seasoned professional to join our team as a Global Regulatory Lead for Biologics. In this critical role, you will be responsible for developing and implementing regulatory strategies...

  • Administrative Support Specialist

    6 days ago

    Princeton, New Jersey, United States Otsuka Pharmaceutical Co., Ltd. Full time

    About Otsuka Pharmaceutical Co., Ltd.Otsuka Pharmaceutical Co., Ltd. is a Japanese multinational pharmaceutical company that offers innovative products and services to improve human health.Job Title: Administrative Support SpecialistWe are seeking an experienced Administrative Support Specialist to provide exceptional administrative support to our senior...

  • Senior Quality Assurance Engineer for Pharmaceutical Software Development

    5 days ago

    Princeton, New Jersey, United States Diversity Nexus Full time

    We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Diversity Nexus.About the RoleIn this key position, you will be responsible for overseeing the quality assurance of software development processes in the pharmaceutical industry. Your expertise will ensure that our products meet global regulatory requirements and exceed...

  • Corporate Meetings Logistics Manager

    7 days ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries Full time

    Sun Pharmaceutical Industries is a leading global pharmaceutical company with a strong presence in the specialty, generics, and consumer healthcare markets. With over 40 manufacturing facilities worldwide, we offer high-quality medicines to more than 100 countries.We are currently seeking an experienced Corporate Meetings Logistics Manager to join our team....

  • Clinical Quality Assurance Associate

    7 days ago

    Princeton, New Jersey, United States Aequor Technologies Full time

    About Aequor TechnologiesWe are a leading provider of innovative solutions in the pharmaceutical industry. Our mission is to deliver high-quality products and services that meet the evolving needs of our customers.Job SummaryWe are seeking an experienced Clinical Quality Assurance Associate to join our team. As a Clinical Quality Assurance Associate, you...

  • Clinical Development Manager

    7 days ago

    Princeton, New Jersey, United States BESTMSLs Full time

    About UsBESTMSLs is a leading company in the clinical trial industry, dedicated to providing exceptional services and expertise to our clients.Job DescriptionWe are seeking an experienced Clinical Trial Liaison Manager to join our team. The successful candidate will be responsible for overseeing site trial delivery, subject recruitment, protocol adherence,...

  • Clinical Development Liaison

    4 weeks ago

    Princeton, New Jersey, United States Gardner Resources Consulting Full time

    Job Title: Medical Science LiaisonAbout the Role:We are seeking a highly skilled Medical Science Liaison to join our team at Gardner Resources Consulting. As a Medical Science Liaison, you will play a critical role in engaging with healthcare partners and providers, communicating strategic objectives, and educating stakeholders on the value and outcomes of...

  • Recruiter for Pharmaceutical Sector

    6 days ago

    Princeton, New Jersey, United States Lynkx Staffing LLC Full time

    Job OverviewTalent Acquisition Manager is a crucial role within Lynkx Staffing LLC, focusing on identifying and attracting top talent in the pharmaceutical industry.About the RoleThis position reports directly to the Director of Talent Acquisition and involves proactively collaborating with business leaders to develop and implement effective talent...

  • Senior Pharmaceutical Data Analyst

    7 days ago

    Princeton, New Jersey, United States United Software Group Full time

    United Software Group is seeking a highly skilled Senior Pharmaceutical Data Analyst to join our team. We offer a competitive salary of $120,000 per year.About the RoleThis is an exciting opportunity for an experienced TrackWise administration and configuration specialist to work with us. As a Senior Pharmaceutical Data Analyst, you will be responsible for...

  • UroGen Medical Affairs Strategic Lead

    5 days ago

    Princeton, New Jersey, United States UroGen Full time

    Job OverviewWe are seeking a highly skilled Associate Director, Medical Affairs to join our team at UroGen.Key Responsibilities:Support Medical Affairs Strategy: Collaborate with internal and external stakeholders to develop and execute medical communications plans aligned with the company's objectives.Operational Support: Provide strategic and operational...

  • Pharmaceutical Construction Project Director

    3 days ago

    Princeton, New Jersey, United States Actalent Full time

    About the OpportunityWe are seeking an experienced Pharmaceutical Construction Project Director to join our New Jersey team. As a key member of our Design-Build Firm, you will be responsible for managing commercial construction projects, including pharmaceutical and manufacturing facilities.

  • Clinical Trial Operations Specialist

    1 week ago

    Princeton, New Jersey, United States BESTMSLs Full time

    About the RoleClinical Trial Liaison Manager at BESTMSLsOverviewThis Hybrid office-based position involves regular travel in the field, overseeing site trial delivery, subject recruitment, protocol adherence, and data quality. Based in North America, you will represent the company in site relations, support study teams with startup and recruitment, and...

  • Pharmaceutical Coordinator

    5 days ago

    Princeton, New Jersey, United States Verbatim Pharma Full time

    Job OverviewWe are seeking a skilled Clinical Trial Assistant Manager to join our team at Verbatim Pharma. This role is an excellent opportunity for individuals with experience in clinical trials and pharmaceutical supply chain management.The ideal candidate will have a strong background in clinical trial services, attention to detail, and excellent...