Regulatory Affairs Manager

3 weeks ago


Somerville, United States Gan & Lee Pharmaceuticals Full time
Job DescriptionJob Description

Summary

This position reports to the VP, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with regulatory agencies

Education and Credentials

• Bachelor of Science Degree in a relevant area is required. Advanced science degree is preferred.

• RAC certification or other equivalent is preferred.

Experience

  • Minimum Bachelor’s degree in a scientific or related discipline, 5+ years of pharmaceutical industry experience, at least 3 years of regulatory CMC experience with US product development. (Must)
  • Deep knowledge of US and EU regulations for biosimilars is preferred.
  • Deep knowledge of regulations for drugs and biologics.
  • Familiarity with GLP/GCP/GMP, clinical laboratory regulations, and licensing.
  • Experience in various regulatory submissions and communication with regulatory agencies.
  • Experience in working in a multi-culture/multi-countries environment is preferred.

Skills

  • Must be proficient with both English and Chinese,including written and oral communication
  • Demonstrated ability to manage multiple and diverse projects concurrently.
  • Demonstrated ability to develop positive relationships and collaborations.
  • Strong analytical skills; a strategic thinker, planner, and implementer.
  • Ability to operate independently with minimal supervision.
  • Strong proficiency in major Microsoft Office products (i.e., Word, Excel, PowerPoint, Project).
  • Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.

Responsibilities

  1. Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package;
  2. Participate as Global Product Strategy Lead in cross-functional teams, including but not limited to, contract research organizations (CROs), functional working groups, global regulatory team, submission team, product development team, to ensure compliance with regulatory requirements;
  3. Author Module 2 and 3 documents for regulatory filings such as INDs/ IMPDs/ CTAs/ MAAs/NDAs/ global registrations and eCTD submissions, ensuring that they meet current regulatory standards.
  4. Drive the preparation and review of regulatory submissions, such as INDs, BLAs, MAAs, meeting packages to ICH member Health Agencies, and supplemental filings ensuring regulatory documents are written per guidelines and timelines.
  5. Manage and track filing submission dates, questions from Regulatory Health Authorities, responses, and approval dates.

Powered by JazzHR

WEgcTnPcTT



  • Somerville, United States AllWays Health Partners Full time

    Mass General Brigham Health Plan is an exciting place to be within the healthcare industry. As a member of Mass General Brigham, we are on the forefront of transformation with one of the world's leading integrated healthcare systems. Together, we are providing our members with innovative solutions centered on their health needs to expand access to seamless...


  • Somerville, United States Fladger Assoc. Inc. Full time

    Job DescriptionJob DescriptionSomerville, NJContract Duration: 12 month unlimited extensionRate: Negotiable Responsibilities:Excellent employment opportunity for a Regulatory Affairs Consultant in the Somerville, NJ area.Represent Regulatory Affairs by attending project team meetings, providing regulatory strategies, reviewing project documentation, and...


  • Somerville, United States Fladger Assoc. Inc. Full time

    Job DescriptionJob DescriptionSomerville, NJContract Duration: 12 month unlimited extensionRate: Negotiable Responsibilities:Excellent employment opportunity for a Regulatory Affairs Consultant in the Somerville, NJ area.Represent Regulatory Affairs by attending project team meetings, providing regulatory strategies, reviewing project documentation, and...


  • Somerville, United States Accordance Search Group Full time

    What if you could join a company rapidly advancing its first candidate to clinic and play a critical role in bringing new medicines to patients through looking at and treating disease in a revolutionary way? What if you could be the first hire in Regulatory Affairs with the opportunity to build a strategy and your team as we expand our clinical pipeline?...

  • Head of Regulatory Affairs

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago


    Somerville, United States Accordance Search Group Full time

    What this position is all about: We are looking for a strategic and results-driven Head of Regulatory Affairs (level commensurate with experience) to lead our regulatory efforts and activities for the advancement of our assets through early clinical development. This individual will play a pivotal role in shaping the regulatory strategy, ensuring compliance,...

  • Finance & Regulatory Reporting Manager

    Found in: Appcast Linkedin GBL C2 - 1 day ago


    Somerville, United States Randstad USA Full time

    This is a hybrid role and will require an onsite presence at Assembly Row in Somerville 1x/week.The Finance & Regulatory Reporting Manager will be part of an interdisciplinary accounting and reporting team responsible for overseeing the monthly journal entries and accounts reconciliations, quarterly & annual regulatory reporting, and annual external audits....


  • Somerville, United States CareerBuilder Full time

    Director for Quality, Safety and Regulatory Education RN License in New Jersey, BSN, master's degree preferred, Professional Certification, CPHQ-Certified Professional in Healthcare Quality highly desirable, Experience Minimum of five years' experience in clinical practice, Prior experience with performance improvement initiatives, and regulatory oversight,...


  • Somerville, United States RWJ Somerset Full time

    Director for Quality, Safety and RegulatoryEducationRN License in New Jersey, BSN, master's degree preferred,Professional Certification,CPHQ-Certified Professional in Healthcare Quality highly desirable,ExperienceMinimum of five years' experience in clinical practice,Prior experience with performance improvement initiatives, and regulatory oversight,Strong...


  • Somerville, United States RWJ Somerset Full time

    Director for Quality, Safety and RegulatoryEducationRN License in New Jersey, BSN, master's degree preferred,Professional Certification,CPHQ-Certified Professional in Healthcare Quality highly desirable,ExperienceMinimum of five years' experience in clinical practice,Prior experience with performance improvement initiatives, and regulatory oversight,Strong...


  • Somerville, United States RWJ Somerset Full time

    Director for Quality, Safety and RegulatoryEducationRN License in New Jersey, BSN, master's degree preferred,Professional Certification,CPHQ-Certified Professional in Healthcare Quality highly desirable,ExperienceMinimum of five years' experience in clinical practice,Prior experience with performance improvement initiatives, and regulatory oversight,Strong...

  • Policy Associate

    3 weeks ago


    Somerville, United States Vanguard Energy Partners, LLC Full time

    Job DescriptionJob DescriptionPolicy AssociateDescriptionThe policy associate is responsible for supporting all aspects of the regulatory requirements for renewable energy projects nationally. They will monitor pending legislation on both federal and State levels, noting trends and key market impacts. They will assist in the filing of requisite applications...

  • Finance Manager

    Found in: Appcast Linkedin GBL C2 - 1 day ago


    Somerville, United States Randstad Full time

    The Finance & Regulatory Reporting Manager will be part of an interdisciplinary accounting and reporting team responsible for overseeing the monthly journal entries and accounts reconciliations, quarterly & annual regulatory reporting, and annual external audits. S/he is responsible for oversight and validation of general ledger account reconciliations...


  • Somerville, NJ, United States RWJ Somerset Full time

    Director for Quality, Safety and RegulatoryEducationRN License in New Jersey, BSN, master's degree preferred,Professional Certification,CPHQ-Certified Professional in Healthcare Quality highly desirable,ExperienceMinimum of five years' experience in clinical practice,Prior experience with performance improvement initiatives, and regulatory oversight,Strong...


  • Somerville, United States Spotlock Full time

    Job DescriptionJob DescriptionSurvey Department ManagerLocation: Somerville, NJWe are seeking a highly qualified and licensed Professional Land Surveyor to lead our firm's Survey Department.Key Responsibilities:As the Survey Department Manager, you will be responsible for:Leadership: Providing visionary leadership to the Survey Department, ensuring...

  • HR Manager

    6 hours ago


    Somerville, United States VDA Full time

    HR Manager HR Manager: VDA, an Experiential Event Design Agency based in Somerville, MA, has been in business since 1985. We've been recognized as one of the Top 100 Event Agencies by Event Marketer for the past three years and Best in Business by Inc Magazine for our community and industry engagement. VDA works on many types of local and nationwide events:...


  • Somerville, United States Generate Biomedicines Full time

    **About Generate:Biomedicines** Generate:Biomedicines is a new kind of therapeutics company - existing at the intersection of machine learning, biological engineering, and medicine - pioneering Generative Biology to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a...


  • Somerville, United States Validation & Engineering Group Full time

    Job DescriptionJob DescriptionValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.We are seeking a...

  • Care Manager

    2 weeks ago


    Somerville, United States CareerBuilder Full time

    Incredible Care Manager opportunity with a rapidly growing tech-enabled care management company headquartered in Boston, MA. The Assessment, Care Manager works collaboratively as part of a care management team to guide prospective families through the initial assessment process, assess consumer and caregiver eligibility for services, develop an initial...

  • Care Manager

    7 days ago


    Somerville, United States Max Populi Full time

    Incredible Care Manager opportunity with a rapidly growing tech-enabled care management company headquartered in Boston, MA. The Assessment, Care Manager works collaboratively as part of a care management team to guide prospective families through the initial assessment process, assess consumer and caregiver eligibility for services, develop an initial...

  • Lab Manager

    1 hour ago


    Somerville, United States Tufts University Full time

    Overview Health and Wellness, within Student Life, is comprised of Counseling and Mental Health Service, Health Service, Health Promotion, Center for Awareness, Resources, and Education, and Administration and Operations. Health and Wellness (H&W) contributes to the educational mission of the university through promoting student wellbeing via clinical,...