Regulatory Operations Director

4 weeks ago

Burlington, Massachusetts, United States Vericel Corporation Full time
Job Title: Director, Regulatory Operations

Job Summary:

Vericel Corporation is seeking a highly experienced Director, Regulatory Operations to join our team. This role will be responsible for managing the operational infrastructure and processes for Vericel products, including submission planning, commitment dates, and submission management.

Key Responsibilities:

  • Oversee the structure of the RIM system to ensure adequate storage, security, and retrieval of regulatory documents.
  • Ensure FDA requirements for regulatory document retention are met.
  • Manage the submission management processes, including document authoring, version control, and links to other documents.
  • Oversee the publishing and electronic submission to FDA and other regulatory agencies.
  • Project manage the planning, tracking, and preparation of technically compliant submissions to achieve FDA and Corporate timelines.
  • Work effectively with cross-functional teams in the planning, tracking, and preparation of regulatory submissions.
  • Contribute to the development of regulatory processes, procedures, and systems to support functional area growth.
  • Work closely with IT business partners on all aspects of regulatory system management.
  • Lead and develop internal regulatory operations staff and manage external vendor relationships.

Requirements:

  • Bachelor's degree (Scientific discipline preferred)
  • Advanced degree (preferred)
  • 10+ years pharmaceutical or biotech industry experience in Regulatory Operations and/or Project Management
  • 8+ years direct Regulatory Operations experience
  • 5+ years of management experience.
  • Experience in eCTD submissions and working knowledge of US and international biologics, drug, and device guidelines and regulations related to regulatory operations required.
  • Experience and knowledge in preparation of 510K's, BLAs, INDs, and supportive amendments and supplements.
  • Experience with device submissions, including humanitarian devices.
  • Extensive experience with Microsoft software, authoring templates (ex. StartingPoint), Adobe Acrobat, and associated plug-ins required.
  • Strong technical and troubleshooting abilities required.
  • Ability to effectively communicate operational strategy, risk, and methods to interdisciplinary teams.
  • Excellent project management, organizational, and communication skills.
  • Ability to work independently as well as part of a team environment.
  • Proven ability to manage multiple projects, identify and resolve regulatory issues.
  • Strong interpersonal skills and the ability to effectively work with others.

Working Conditions and Physical Demands:

  • Occasional travel (5-10%)

EEO Statement:

Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability.

  • Director, Technical Operations CMC Team Lead

    4 weeks ago

    Burlington, Massachusetts, United States Sarepta Therapeutics Full time

    About the RoleSarepta Therapeutics is seeking a highly skilled and experienced Director, Technical Operations CMC Team Lead to join our team. As a key member of our Global Program Team, you will be responsible for leading critical elements of the CMC development of our Gene Therapy and RNA portfolio.Key ResponsibilitiesProvide program management and...

  • Hotel Operations Director

    3 weeks ago

    Burlington, Massachusetts, United States Boston Marriott Burlington Full time

    At Boston Marriott Burlington, we are committed to delivering exceptional guest experiences and maintaining operational efficiency. As the General Manager, you will be responsible for the overall operations, strategy, and growth of the hotel.This role requires strong leadership, strategic thinking, and exceptional management skills to ensure the hotel's...

  • Director of Software Development

    3 weeks ago

    Burlington, Massachusetts, United States Oracle Full time

    Job Title: Director of Software DevelopmentJob Summary:Oracle is seeking a highly experienced Director of Software Development to lead our Java Platform Group. As a seasoned leader, you will be responsible for managing the development and release of new Java platform features, as well as managing a geographically distributed development team.Key...

  • Director of Patient Advocacy

    4 weeks ago

    Burlington, Massachusetts, United States PharmaEssentia U.S.A. Full time

    Job DescriptionPharmaEssentia U.S.A. is seeking an experienced professional to establish and foster impactful relationships with patient advocacy organizations in therapeutic areas relevant to our pipeline. The Director of Patient Advocacy will be responsible for ensuring that the patient voice is amplified in the organization. This is a highly collaborative...

  • IT Director

    3 weeks ago

    Burlington, Massachusetts, United States Fractyl Health, Inc Full time

    We are seeking a highly skilled and experienced IT Director to lead and develop strategies around IT operations at Fractyl Health, Inc.As the IT Director, you will be responsible for establishing procedures around IT assets through managing the IT help desk and external vendors.This position will cross-functionally partner with Fractyl's internal...

  • Associate Director, Clinical Science Lead

    3 weeks ago

    Burlington, Massachusetts, United States Cardurion Pharmaceuticals, Inc Full time

    Job DescriptionCardurion Pharmaceuticals, Inc. is seeking a highly skilled Associate Director, Clinical Science to join our Clinical Development team. This role will play a critical part in supporting the execution of our mission to bring new therapies to patients with cardiovascular disease.Key Responsibilities:Act as primary point of contact for medical...

  • Software Development Director

    3 weeks ago

    Burlington, Massachusetts, United States Oracle Full time

    Job DescriptionThe Java Platform Group at Oracle is seeking an experienced and highly motivated Director of Software Development to lead our team in delivering the Java platform used by millions of developers worldwide.This is a unique opportunity to join a world-class team and contribute to the success of Java by managing the delivery of new language and...

  • Financial Operations Manager

    4 weeks ago

    Burlington, Massachusetts, United States AUO Display Plus America Corp Full time

    Job OverviewAs a key member of the AUO Display Plus America Corp team, the Accounting Manager will be responsible for maintaining accurate and up-to-date financial records, ensuring compliance with regulatory requirements, and providing financial insights to support business decisions. The ideal candidate will have a strong background in accounting and...

  • Senior Director of Financial Planning and Analysis

    4 weeks ago

    Burlington, Massachusetts, United States Jobot Full time

    Unlock Your Potential as a Senior Director of FP&AThis is an exceptional opportunity to join a rapidly expanding manufacturing company as a Senior Director of Financial Planning and Analysis. As a key member of our leadership team, you will play a pivotal role in shaping the financial future of our organization.Key Responsibilities:Lead the FP&A team in the...

  • Associate Director, CMC Procurement Specialist

    4 weeks ago

    Burlington, Massachusetts, United States Sarepta Therapeutics Full time

    About the RoleWe are seeking a highly motivated and experienced individual to join our growing Global Procurement & Strategic Sourcing team at Sarepta Therapeutics. As an Associate Director, CMC Procurement, you will have the opportunity to deliver significant value and support our rapidly growing TechOps organization.Key ResponsibilitiesCollaborate with...

  • Senior Director Software Development Lead

    3 weeks ago

    Burlington, Massachusetts, United States Oracle Full time

    Lead the Java Platform GroupThe Java Platform Group is seeking an experienced Senior Director of Software Development to lead the development of the Java platform.As a seasoned leader, you will be responsible for advancing the Java programming language with a focus on reliability, scalability, resilience, security, and performance.You will manage development...

  • Associate Director, CMC Procurement Lead

    4 weeks ago

    Burlington, Massachusetts, United States Sarepta Therapeutics Full time

    About Sarepta TherapeuticsSarepta Therapeutics is a leading biopharmaceutical company focused on developing innovative treatments for rare genetic diseases. Our mission is to harness the power of genetic medicine to transform the lives of patients and their families.Job SummaryWe are seeking an experienced Associate Director, CMC Procurement to join our...

  • Restaurant Director

    4 weeks ago

    Burlington, Massachusetts, United States Karma Full time

    Restaurant ManagerKarma is a rapidly expanding company with a strong presence in the Northshore area. We are seeking a seasoned Restaurant Manager to join our team and contribute to our growth.Key Responsibilities:Partner with the management team to develop and implement effective training programs for front-of-house staff.Oversee daily shift operations,...

  • Senior Manager, Clinical Drug Supply Chain Expert

    4 weeks ago

    Burlington, Massachusetts, United States Cardurion Pharmaceuticals, Inc Full time

    Job SummaryWe are seeking a highly experienced Senior Manager, Clinical Drug Supply to join our Clinical Drug Supply Team at Cardurion Pharmaceuticals, Inc. This role will be responsible for managing the supply chain of clinical trial materials, ensuring timely and efficient delivery of high-quality products to support our global clinical trials.Key...

  • Product Analysis Engineer

    4 weeks ago

    Burlington, Massachusetts, United States Spectraforce Technologies Full time

    Job Title:Product Analysis EngineerLocation:Duration: 6 MonthsMain Purpose of Role As a Product Analysis Engineer, you will be responsible for performing failure analysis on explanted biomedical implant products. You will provide technical expertise to the Product Analysis Laboratory and work collaboratively with cross-functional teams to identify root...

  • Hospice Triage Nurse

    4 weeks ago

    Burlington, Massachusetts, United States Tufts Medicine Care at Home Full time

    Job Profile SummaryThis role focuses on delivering high-quality, patient-centered care in accordance with physician orders. Key responsibilities include assessing, planning, implementing, and evaluating patient care needs, as well as providing clinical support tasks within the scope of practice. A professional individual contributor role that may direct the...

  • Automotive Service Director

    3 weeks ago

    Burlington, Massachusetts, United States Midas - AMG Enterprises Full time

    Job OverviewMidas - AMG Enterprises is seeking an experienced Automotive Service Manager to oversee the daily operations of our busy Automotive Repair Shop. As a key member of our team, you will be responsible for managing and directing our team of technicians, ensuring exceptional customer service, and driving sales growth.Key ResponsibilitiesDeliver...

  • Deputy General Counsel

    3 weeks ago

    Burlington, Massachusetts, United States FirstLight Power Full time

    About the RoleWe are seeking an experienced Deputy General Counsel to join our Legal team at FirstLight Power. As a key member of our team, you will provide general legal and business advice to our operations, commercial, and finance departments, as well as negotiate and draft complex commercial contracts.Key ResponsibilitiesProvide legal and business advice...

  • Electrical Engineer

    3 weeks ago

    Burlington, Massachusetts, United States BRIOHEALTH SOLUTIONS INC Full time

    Electrical Engineer Job DescriptionBrioHealth Solutions Inc. is seeking a talented and experienced Electrical Engineer to join our team. As a key member of our engineering team, you will be responsible for designing, developing, and testing electronics for our innovative wearable medical devices.Key Responsibilities:Design and develop electronics for...

  • Senior Facilities Engineer

    4 weeks ago

    Burlington, Massachusetts, United States Vericel Corporation Full time

    Job OverviewVericel Corporation is seeking a highly skilled Senior Facilities Engineer to join our team in Burlington, MA. This role will be responsible for supporting the startup, troubleshooting, commissioning, qualification, and engineering lifecycle initiation of manufacturing equipment, utilities, and the facility.Key Responsibilities:Work with...