Associate Director

1 month ago

Boston, United States Dechra Pharmaceuticals PLC Full time

Vacancies

Associate Director/Director, Biologics CMC Regulatory Affairs

Job Introduction

This is a US remote role, with a preference for candidates based in the Boston area.

Invetx, a division of Dechra, is a veterinary biotechnology company focused on developing protein-based therapeutics for chronic conditions in companion animals, with an emphasis on monoclonal antibodies (mAbs). Our proprietary innovation platform integrates leading industry technologies to create species-specific, half-life extended mAbs that are longer-lasting, safe, effective, and more affordable than current treatments. As part of Dechra, a global leader in veterinary pharmaceuticals, Invetx supports Dechra‘s mission to sustainably improve global animal health and welfare.

The Associate Director/Director Biologics CMC Regulatory Affairs will play a key role in the progression of Biologics pipeline candidates by providing regulatory affairs related oversight of key CMC development and manufacturing efforts that are currently ongoing both internally and externally through a network of third-party providers including CDMOs and CROs.

The primary function of the Associate Director/Director of Biologics CMC Regulatory Affairs is leading the development and implementation of biologics CMC global regulatory strategies for FDA, USDA and other agency regulated programs in development and registration preparation for biologics animal health pipeline programs. This responsibility covers all major regions and international markets. The person selected for the role will serve as a key member with an opportunity to apply your experience and skills across all aspects of Biologics CMC Regulatory Affairs necessary to support pivotal phase clinical studies, commercial product launch and post commercial launch support. Additionally, the role will interface with CMC Development, Manufacturing, Clinical, Quality, Discovery, and external CDMO teams to maintain coherence in submission of regulatory content and compliance in quality.

Role Responsibility

  • Leads and oversees the development and preparation of Biologics CMC-related regulatory submission documents ensuring they are organized, systematic and meet current regulatory standards of FDA, EMA and/or USDA and are of high quality. The submissions include, but not limited to INAD, NADA, MAA and other regulatory agency submissions.
  • Develops and implements CMC global regulatory strategies, ensuring technical accuracy and regulatory compliance while adhering to timelines and e-submission requirements.
  • Collaborates closely with Dechra‘s other regulatory team members to devise robust global regulatory CMC strategies and risk mitigation for FDA, USDA and other agency regulated programs. Contributes to the development of comprehensive global regulatory strategic plans, to enable successful regulatory submissions and approvals.
  • Engages in effective communication and collaboration with cross-functional teams, within CMC and with Clinical, to coordinate efforts and achieve regulatory compliance and operational excellence.
  • Leads and/or participates in regulatory agency interactions or meetings for CMC relevant topics.
  • Supports preparation of comprehensive and stage appropriate briefing books to enable regulatory agency interactions for CMC related questions and topics.
  • Works with quality lead and conducts assessments of change controls and delivers regulatory evaluations of quality changes in production and quality control.
  • Demonstrates proficiency in interpreting and applying regulatory guidance, provides regulatory guidance, recommendations, and solutions to cross-functional teams and key stakeholders.
  • Collaborates with CMC and Regulatory teams to develop and enhance internal processes to for creating high-quality CMC regulatory documents. This includes streamlining the writing, review, and approval process, as well as critically reviewing and reconciliation of team comments.
  • Supports best practice for regulatory CMC compliance activities including, but not limited to, change controls, post-marketing commitments, product complaints, and regulatory inspections. Remains current on CMC regulatory intelligence including guidelines and compendial requirements.
  • Recommends changes to policies and establishes procedures that affect section or multiple disciplines.
  • Represent Dechra in a consistent highly professional manner with integrity, respect, determination and in an ethical manner. Foster a team culture of collaboration, communication, ownership, and accountability.


The Ideal Candidate
  • 9+ years of industry experience in CMC regulatory function
  • Degree in Science (Biology, Biochemistry, Chemistry, Bioengineering, etc.), BS/MS/Ph.D
  • Proficiency and hands-on experience in regulatory submission and approval processes from new product development to commercialization
  • Proven ability to navigate complex CMC regulatory issues and requirements effectively
  • Previous regulatory experience in biologics development, especially in monoclonal antibody-based products is preferred
  • Knowledge of animal health industry regulatory guidelines for CMC under FDA, EMA, USDA, and other regulatory agencies is essential
  • Extensive track record in the development and maintenance of regulatory CMC documents, with a strong command of regulatory standards and requirements
  • Ability to travel (domestic/international) approximately 15-20%

Desirable
  • Passionate about animal health and getting innovative veterinary medicines to market
  • Regulatory exposure in global regions beyond US and EU, such as Asia
  • Working knowledge and understanding of current regulations and industry trends for biologics product development and manufacturing


About the Company

As a people first values-based culture, we provide free weekly wellness sessions focused on our employee‘s physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and other incentives for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.#J-18808-Ljbffr

  • Associate Technical Director

    3 weeks ago

    Boston, United States Emerson College Full time

    The Associate Technical Director provides hands-on support for and limited supervision in the performance and theatrical facilities of the Office of the Arts (OA), including but not limited to, the Cutler Majestic Theatre, Robert J. Orchard Stage, Se Director, Technical, Associate, Technician, Operations, Production, Technology, Education

  • Associate Technical Director

    2 weeks ago

    Boston, United States Emerson College Full time

    The Associate Technical Director provides hands-on support for and limited supervision in the performance and theatrical facilities of the Office of the Arts (OA), including but not limited to, the Cutler Majestic Theatre, Robert J. Orchard Stage, Se Director, Technical, Associate, Technician, Operations, Production, Technology, Education Learn More

  • Associate Executive Director

    3 weeks ago

    Boston, United States Brightview Senior Living Full time

    About Us: Overview: Are you working in senior living and thinking about your future? Perhaps you've thought about being an Executive Director in a senior living community one day. Brightview Senior Living has a robust training program to help get you there! While learning the important facets of a community's overall operations, the Associate Executive...

  • Associate Executive Director

    3 weeks ago

    Boston, United States Brightview Senior Living Full time

    About Us: Overview: Are you working in senior living and thinking about your future? Perhaps you've thought about being an Executive Director in a senior living community one day. Brightview Senior Living has a robust training program to help get you there! While learning the important facets of a community's overall operations, the Associate Executive...

  • Associate Technical Director

    1 week ago

    Boston, United States Emerson College Full time

    Join our community and experience Emerson College!The Associate Technical Director provides hands-on support for and limited supervision in the performance and theatrical facilities of the Office of the Arts (OA), including but not limited to, the Cutler Majestic Theatre, Robert J. Orchard Stage, Semel and Greene Theaters, Jackie Liebergott Black Box...

  • Director/ Associate Director of Business Development

    1 month ago

    boston, United States ChemPartner Full time

    Director/ Associate Director/Manager of Business DevelopmentShanghai ChemPartner Boston, Massachusetts, United States (Remote)Director/ Associate Director/Manager of Business Development, BostonCompany OverviewThis is an exciting opportunity to join a dynamic team and play a contributing role at ChemPartner, a leading China–based CRO specializing in drug...

  • Associate Director, GreenLight Boston

    4 weeks ago

    Boston, United States EPIP Full time

    GreenLight Boston is currently seeking a dynamic, passionate, and collaborative Associate Director. The Associate Director will work in collaboration with and serve as a thought partner to the Boston Senior Executive Director. The Associate Director will manage the day-to-day operations of the team, ensuring on-track progress on the site’s ambitious plans...

  • Associate Director

    7 months ago

    Boston, United States Khoury College Full time

    About the OpportunityJob SummaryAbout the College of Arts, Media and DesignWe are a vibrant community of creators, designers, technologists, and communicators applying creativity across disciplines and harnessing emerging technologies to advance human potential and solve the challenges of the future.Powered by experience-driven teaching, learning and...

  • Co-Director or Associate Director, Hematology Laboratory and Hemopathology

    2 months ago

    Boston, United States Boston Children's Hospital Full time

    The Departments of Laboratory Medicine (DLM) and Pathology at Boston Childrens Hospital (a teaching affiliate of Harvard Medical School) are seeking a Hemopathologist with the appropriate training, experience, and established skill set to join the faculty as a Co-Director or Associate Director of the Hematology Laboratory in DLM and member of the...

  • Associate Director

    4 weeks ago

    Boston, United States Massachusetts Nonprofit Network Full time

    Associate Director, Gray Nation EnduranceNational Brain Tumor SocietyCommunity here. Breakthroughs ahead.Job DescriptionAbout NBTS:National Brain Tumor Society (NBTS) unrelentingly invests in, mobilizes and unites our community to discover a cure, deliver effective treatments, and advocate for patients and their care partners. NBTS is a leading policy...

  • Associate Director

    4 weeks ago

    Boston, United States Massachusetts Nonprofit Network Full time

    Associate Director, Gray Nation EnduranceNational Brain Tumor SocietyCommunity here. Breakthroughs ahead.Job DescriptionAbout NBTS:National Brain Tumor Society (NBTS) unrelentingly invests in, mobilizes and unites our community to discover a cure, deliver effective treatments, and advocate for patients and their care partners. NBTS is a leading policy...

  • Associate Media Director

    2 months ago

    boston, United States Amp Full time

    Associate Media Director (Hybrid in Boston)We are looking for an Associate Media Director to join our growing Media Team!The Associate Media Director role will develop and manage the day-to-day media strategy, planning and execution of all assigned client programs, working across a mix of awareness and performance marketing media channels within both...

  • Associate Media Director

    3 months ago

    boston, United States Amp Full time

    Associate Media Director (Hybrid in Boston)We are looking for an Associate Media Director to join our growing Media Team!The Associate Media Director role will develop and manage the day-to-day media strategy, planning and execution of all assigned client programs, working across a mix of awareness and performance marketing media channels within both...

  • Associate Media Director

    3 months ago

    Boston, United States Amp Full time

    Associate Media Director (Hybrid in Boston)We are looking for an Associate Media Director to join our growing Media Team!The Associate Media Director role will develop and manage the day-to-day media strategy, planning and execution of all assigned client programs, working across a mix of awareness and performance marketing media channels within both...

  • Associate Media Director

    5 days ago

    Boston, United States Amp Full time

    Associate Media Director (Hybrid in Boston, MA)We are looking for an Associate Media Director to join our growing Media Team!The Associate Media Director role will develop and manage the day-to-day media strategy, planning and execution of all assigned client programs, working across a mix of awareness and performance marketing media channels within both...

  • Associate Director/Director

    2 days ago

    Boston, United States Anlitiks Inc. Full time

    Job Title: Associate Director/Director of Health Economics and Outcomes Research (HEOR)Job Summary:The Associate Director / Director of HEOR will lead and oversee scientific research projects, ensuring high-quality deliverables and client satisfaction. This role involves strategic client consultation, study design, protocol development, and collaboration...

  • Associate Director, Global Marketing, Heme

    3 weeks ago

    Boston, United States Vertex Pharmaceuticals Full time

    Associate Director, Global Marketing, Heme. Location: Boston, MA (3 days onsite, 2 days remote weekly)General Summary:Vertex is seeking a talented leader to join our Global Commercial Strategy (GCS) team supporting CASGEVY (exagamglogene autotemcel, Director, Associate, Marketing, Global, Business Services, Strategy

  • Associate Director Data Analysis

    3 weeks ago

    Boston, United States Dana-Farber Cancer Institute Full time

    Overview The Associate Director, Data Analysis and Management, under the Director and the PI of the Cohort Studies, is responsible for the oversight, management and coordination of the data analysis and management related to cohort and translational studies in the Department of Breast Oncology. The primary focus of the Associate Director, Data Analysis and...

  • Associate Director Data Analysis

    1 month ago

    Boston, United States Dana-Farber Cancer Institute Full time

    The Associate Director, Data Analysis and Management, under the Director and the PI of the Cohort Studies, is responsible for the oversight, management and coordination of the data analysis and management related to cohort and translational studies in the Department of Breast Oncology. The primary focus of the Associate Director, Data Analysis and Management...

  • Associate Director Data Analysis

    4 weeks ago

    Boston, United States Dana-Farber Cancer Institute Full time

    The Associate Director, Data Analysis and Management, under the Director and the PI of the Cohort Studies, is responsible for the oversight, management, and coordination of the data analysis and management related to cohort and translational studies in the Department of Breast Oncology. The primary focus of the Associate Director is the oversight of analytic...