Associate Director, Regulatory Operations-hybrid

3 weeks ago

Philadelphia, United States Adaptimmune Full time
Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.

Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.

PRIMARY RESPONSIBILITY

This role will lead the Regulatory Operations activities within Global Regulatory Affairs. This role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs, and supporting development of Regulatory Operations procedures and practices. The Associate Director of Regulatory Operations is responsible for the assembly, publishing, QC, submission, and archiving of regulatory filings to global Health Authorities (HA) in an efficient and timely manner.

Key Responsibilities
  • Collaborate with the regulatory team, and cross-functional team members and external contractors/vendors/consultants as needed, to support the planning, preparation, formatting, publishing, QC, submission and archiving of global regulatory submissions (i.e., INDs/CTAs/BLAs and amendments/supplements, responses to health authority requests for information, health authority briefing documents, etc).
  • Provide project management support in generation of timelines for Regulatory interactions and submissions
  • Organize, archive, and track Health Authority correspondences, submissions, and questions/commitments
  • Collaborate with our external publishing vendor(s) on submission publishing activities to assure on time regulatory submissions in accordance with project goals and timelines. Managing the projected regulatory submissions spreadsheet and assuring alignment of resources and timelines with the external publishing vendor
  • Provide business ownership of the IT systems within the scope of Regulatory Operations, such as Veeva RIM, submission publishing, CTIS, EUDAMED, and others as necessary
  • Be responsible for the development, implementation, and ongoing training to the organization on Regulatory Operations processes and systems, including but not limited to changes to existing processes or systems, the introduction of new processes and/or systems, and the training of new employees as necessary. In addition, be responsible for the oversight of user access management to Regulatory systems.
  • Partner with IT on the change management, release management, and ongoing validation of all Regulatory Operation computer systems
  • Build the Regulatory Operations infrastructure and oversee development of standard operating procedures, training materials, and job aids with respect to Regulatory Affairs and Operations
  • Coordinate collaboration with responsible departments and oversee preparation, review, and collection of documentation for regulatory submissions
  • Provide critical review of documentation supporting regulatory applications
  • Maintaining templates and style guides for regulatory submissions and providing internal regulatory document preparation technical support
  • Support the creation and monitoring of functional KPIs

Qualifications & Experience

Required
  • BA/BA degree required
  • 6-8+ years experience in the pharmaceutical/biotech industry, with a minimum of 5 years of Regulatory Operations and eCTD/submission publishing experience
  • Thorough understanding of ICH/US/EMA regulations and guidelines related to regulatory submissions and standards.
  • Experience with implementing / maintaining / utilizing a RIM system. Experience in Business or System Administrator is a plus
  • Experience with managing vendors/consultants/partners (e.g. external publishing vendor)
  • Strong understanding of Regulatory Operation comprehensive role
Desirable
  • Prior regulatory operations experience in cell and gene therapy and/or oncology is strongly preferred
  • Experience with BLAs/NDAs/MAAs preferred
  • Expertise in Veeva RIM, system implementation experience a plus


At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.

  • Associate Director, Regulatory Operations-hybrid

    2 weeks ago

    Philadelphia, United States Adaptimmune Full time

    Job DescriptionJob DescriptionAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house...

  • Senior Associate, Regulatory Promotional Operations

    3 weeks ago

    Philadelphia, Pennsylvania, United States Digitas Health Full time

    Job Description The Senior Associate, Regulatory Review must follow the protocol established by our pharmaceutical clients when submitting marketing materials for regulatory review. This includes preparing completed editorial content to the Medical-Legal-Regulatory (MLR) review board (a board of experts typically consisting of medical doctors, lawyers and...

  • Senior Director, Regulatory Affairs CMC

    15 hours ago

    Philadelphia, United States Meet Full time

    Senior Director, Regulatory Affairs CMCHybrid - Philadelphia, PAMeet has partnered with a very well-established pharma with hundreds of approved products. They are looking for a Senior Director of Regulatory CMC (biologics) to join their team. This position will be working across the company's mid-stage, new development pipeline and will be reporting into...

  • Senior Director, Regulatory Affairs CMC

    1 week ago

    Philadelphia, United States Meet Full time

    Senior Director, Regulatory Affairs CMCHybrid - Philadelphia, PAMeet has partnered with a very well-established pharma with hundreds of approved products. They are looking for a Senior Director of Regulatory CMC (biologics) to join their team. This position will be working across the company's mid-stage, new development pipeline and will be reporting into...

  • Sr. Regulatory Operations Specialist

    1 week ago

    Philadelphia, United States Piper Companies Full time

    Piper Companies is currently seeking a Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in Philadelphia, PA (Hybrid Schedule). Responsibilities for the Sr. Regulatory Operations Specialist ·       Coordinate diverse regulatory submissions by collaborating with internal teams and stakeholders,...

  • Manager, Regulatory Review

    3 weeks ago

    Philadelphia, Pennsylvania, United States Digitas Health Full time

    Job Description The Manager, Regulatory Review manages a team of Associates and Senior Associates to ensure marketing materials for a client (or group of clients) follow the protocol established by our pharmaceutical clients for regulatory review. You will contribute in establishing procedures for our teams and advising on specific projects to aid smooth...

  • Sr. Regulatory Operations Specialist

    1 week ago

    Philadelphia, PA, United States Piper Companies Full time

    Piper Companies is currently seeking a  Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in  Philadelphia, PA (Hybrid Schedule).   Responsibilities for the Sr. Regulatory Operations Specialist · Coordinate diverse regulatory submissions by collaborating with internal teams and stakeholders, and...

  • Sr. Regulatory Operations Specialist

    1 week ago

    Philadelphia, PA, United States Piper Companies Full time

    Piper Companies is currently seeking a  Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in  Philadelphia, PA (Hybrid Schedule).   Responsibilities for the Sr. Regulatory Operations Specialist · Coordinate diverse regulatory submissions by collaborating with internal teams and stakeholders, and...

  • Associate Director, Cmc Regulatory Affairs

    4 weeks ago

    Philadelphia, United States GSK Full time

    **Site Name**: Durham Blackwell Street, USA - Pennsylvania - Philadelphia **Posted Date**: Apr 17 2024 - Does leading and delivering Chemistry and Manufacturing Controls regulatory strategy interest you? If so, this role may be for you! _ This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities...

  • Sr. Regulatory Operations Specialist

    1 week ago

    Philadelphia, PA, US Piper Companies Full time

    Piper Companies is currently seeking a Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in Philadelphia, PA (Hybrid Schedule). Responsibilities for the Sr. Regulatory Operations Specialist ·       Coordinate diverse regulatory submissions by collaborating with internal teams and stakeholders,...

  • Sr. Regulatory Operations Specialist

    7 days ago

    Philadelphia, PA, US Piper Companies Full time

    Piper Companies is currently seeking a Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in Philadelphia, PA (Hybrid Schedule). Responsibilities for the Sr. Regulatory Operations Specialist ·       Coordinate diverse regulatory submissions by collaborating with internal teams and stakeholders,...

  • Regulatory Operations Coordinator

    6 days ago

    Philadelphia, United States Piper Companies Full time

    Piper Companiesis looking for aRegulatory Operations Coordinatorto be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA .Responsibilities for the Regulatory Operations Coordinatorinclude: Work with internal teams and stakeholders to build IND & CTA dossier content plans and...

  • Regulatory Operations Coordinator

    1 week ago

    Philadelphia, United States Piper Companies Full time

    Piper Companies is looking for a Regulatory Operations Coordinatorto be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA. Responsibilities for the Regulatory Operations Coordinatorinclude: Work with internal teams and stakeholders to build IND & CTA dossier content...

  • Regulatory Operations Coordinator

    1 week ago

    Philadelphia, United States Piper Companies Full time

    Piper Companies is looking for a Regulatory Operations Coordinator to be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA. Responsibilities for the Regulatory Operations Coordinator include:Work with internal teams and stakeholders to build IND & CTA dossier content...

  • Manager, Regulatory Affairs-hybrid

    2 weeks ago

    Philadelphia, United States Adaptimmune Full time

    Job DescriptionJob DescriptionAdaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across...

  • Manager, Regulatory Affairs-hybrid

    3 weeks ago

    Philadelphia, United States Adaptimmune Full time

    Job DescriptionJob DescriptionAdaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across...

  • Associate/Manager – CMC Regulatory

    2 weeks ago

    Philadelphia, Pennsylvania, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Associate Director

    3 days ago

    Philadelphia, United States Drexel University Full time

    Associate Director Job no: 503064 Work type: Full-Time Location: Hybrid/Flexible Work Arrangement, Other - Philadelphia, PA Categories: Drexel University, University Communications Job Summary The Internal Communications & Publications Team in the University's Division of University Marketing & Communications seeks a multi-talented editor and writer to...

  • Director, Quality Operations

    7 days ago

    Philadelphia, United States Global Life Science Hub Full time

    Global Life Science Hub is proud to announce an exciting partnership with a leading global trailblazer who is revolutionizing pharmaceutical excellence with integrated services spanning from drug development to commercialization. With ambitious plans to expand their Pennsylvania site by 3x fold this year, were excited to be leading a search for a brand-new...

  • Director, Quality Operations

    2 weeks ago

    Philadelphia, United States Global Life Science Hub Full time

    Global Life Science Hub is proud to announce an exciting partnership with a leading global trailblazer who is revolutionizing pharmaceutical excellence with integrated services spanning from drug development to commercialization. With ambitious plans to expand their Pennsylvania site by 3x fold this year, were excited to be leading a search for a brand-new...