Sr. Director, Global Regulatory CMC

2 months ago

Stevenage UK, Hertfordshire, United Kingdom Spur Therapeutics Full time

Why Spur?

Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists, physicians and other professionals who are singularly focused on using cutting-edge science and technology to transform the treatment of serious and debilitating chronic diseases.


What We Are Trying to Accomplish

We are a clinical-stage biotech company developing transformative adeno-associated virus (AAV) vector-mediated gene therapies. Founded in 2015, Spur is focused on developing innovative, one-time treatments that set new standards of care. Our integrated gene therapy platform includes in-house capabilities in research, protein engineering and clinical development, and we optimize every component of our product candidates to develop first- and best-in-class gene therapies. We are currently advancing a highly differentiated gene therapy candidate in a Phase 1/2 clinical trial in people with Gaucher disease. We are working on additional programs in research, with a focus on CNS and cardiovascular diseases, to reach even more patients with our potentially life-changing treatments. Spur is global, with research facilities and offices in Stevenage, UK, and offices in Boston and New York.


How We Will Do It

We are relentless in our pursuit of transformative medicines for patients. We take innovation seriously and know we need to be bold both in our science and in every aspect of our work. We also know we can only achieve these things together, so we act as one Spur and expect that of each colleague in the company. We always do the right thing – the trust of patients and their caregivers is critical to our success. If you have an entrepreneurial mindset, are willing to work hard to transform the lives of patients, and share our values, then Spur could be the place for you.


Role Purpose

This is a hybrid role based at the Stevenage, UK or Boston, MA office location. The Sr. Director Regulatory CMC is responsible for overseeing the development and implementation of global regulatory CMC strategies for assigned Spur global gene therapy programs, including those both in the clinic and in development. The position will provide strategic and operational leadership for regulatory CMC activities, interfacing with CMC, Clinical, and Clin Reg teams. Functions include CMC regulatory strategy, submission generation in tandem with CMC, submission reviews, and health authority interactions. Spur is rapidly embarking on a phase 3 program with aggressive timelines for enrollment and application. We are also actively establishing a new CDMO for the phase 3 asset. This position will be heavily involved in ensuring timely and coordinated preparedness for both.


Role and Responsibilities

  • Develops CMC regulatory strategy for Spur development-phase projects, including identifying potential regulatory challenges and strategies for managing regulatory risk
  • Works with CMC to define topics for scientific advice interactions and leads meeting preparation including providing strategic regulatory input into the structure and content of briefing documents
  • Provides strategic regulatory input into the structure and content of core CMC regulatory documents and provides regulatory review of content
  • Ensures appropriate cross functional input to CMC regulatory questions and works with cross functional colleagues to respond to regulatory questions in a timely manner
  • Contributes overall project strategy via membership of the project teams
  • Provides CMC regulatory representation to relevant sub-teams such as CMC teams and regulatory teams
  • Collaborates with cross-functional colleagues to ensure consistency of approach to CMC regulatory challenges across the portfolio/platform
  • Leads CMC regulatory meetings, ensuring appropriate input from SMEs and ensuring advice and commitments are clear
  • Maintains an awareness of CMC development activities to ensure regulatory aspects are appropriately considered
  • Maintains an awareness of CMC regulatory guidance and intelligence and ensures this is considered in project CMC strategy


Qualifications and Experience Required

  • Strong scientific background, preferably in Biological Sciences or Pharmacy/Chemistry
  • At least 10 years’ experience of working in CMC regulatory disciplines in a pharmaceutical/ biotech company
  • Knowledge and experience of the requirements for CMC development of biologics for registration including an appreciation of the development of manufacturing processes and analytical strategies
  • Experience of developing process control strategies in line with regulatory expectations
  • Detailed knowledge of CMC regulatory requirements throughout development and registration
  • Demonstrable experience of providing strategic regulatory input to CMC strategy
  • Experience of participating in and leading preparation for, regulatory meetings
  • Significant experience of late stage development


Skills Required

  • Excellent communication and interpersonal skills and ability to work collaboratively in matrix teams
  • Excellent written communication and presentation skills
  • Proficient user of common business computer packages, collaborative tools and RIMS
  • Ability to manage multiple activities, respond to changing business demands and deliver to short timelines
  • Ability to work autonomously and within a multi-disciplinary and multi-national team environment
  • Ability to make strategic decisions with respect to CMC regulatory content and strategy
  • Effective time management
  • Ability to travel to meetings in Europe, US or further afield as the role requires

  • Director of Global Regulatory Compliance

    7 days ago

    Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time

    About the RoleAt Spur Therapeutics, we are dedicated to revolutionizing gene therapy for patients worldwide. We are seeking an experienced Sr. Director, Global Regulatory CMC to join our team and contribute to our mission.The successful candidate will be responsible for developing and implementing global regulatory CMC strategies for assigned Spur gene...

  • Regulatory Affairs Director, Gene Therapy

    1 week ago

    Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time

    Job DescriptionSr. Director Regulatory CMC Job Summary:The Sr. Director Regulatory CMC will lead the development and implementation of global regulatory CMC strategies for assigned Spur global gene therapy programs. This role will provide strategic and operational leadership for regulatory CMC activities, interfacing with CMC, Clinical, and Clin Reg teams.

  • Senior Manager, CMC Regulatory Affairs

    6 days ago

    Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time

    Job DescriptionWe are looking for a highly skilled Sr. Director, Global Regulatory CMC to lead our regulatory CMC strategy development and implementation for our gene therapy programs. The ideal candidate will have at least 10 years of experience in CMC regulatory disciplines in a pharmaceutical/biotech company.The role will involve:Developing CMC regulatory...

  • Global CMC Regulatory Expert

    7 days ago

    Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time

    About the OpportunityWe offer a competitive salary of $175,000 per annum, plus benefits. The Sr. Director Regulatory CMC will have the opportunity to work on cutting-edge gene therapies, contribute to the development of innovative treatments, and collaborate with a talented team of professionals.This is an exciting opportunity to join a rapidly growing...

  • Global Regulatory Compliance Officer

    7 days ago

    Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time

    Sr. Director Regulatory CMC Job DescriptionThis Sr. Director Regulatory CMC position is a key role within our organization, responsible for overseeing global regulatory CMC strategies for assigned Spur gene therapy programs. If you have a strong scientific background and at least 10 years of experience in CMC regulatory disciplines, we encourage you to apply...

  • CMC Director

    7 days ago

    Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time

    Job Title: Senior Director, Biologics Regulatory CMCThe estimated salary for this role is $180,000 - $220,000 per annum, depending on experience and location. We are looking for a highly experienced Senior Director to oversee the development and implementation of global regulatory CMC strategies for our assigned gene therapy programs.This is a hybrid role...

  • Regulatory Affairs Director

    1 month ago

    Stevenage, Hertfordshire, United Kingdom GSK Full time

    Job DescriptionGSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty and general medicines.We are currently seeking a Regulatory Affairs Director - CMC to join our team in the UK. The successful candidate will have a strong...

  • Senior Director, Biologics Regulatory CMC

    7 days ago

    Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time

    About the RoleWe are seeking an exceptional candidate to lead our CMC regulatory team and develop global regulatory strategies for our gene therapy programs. As Senior Director, Biologics Regulatory CMC, you will be responsible for ensuring timely and coordinated preparedness for regulatory submissions.You will work closely with cross-functional teams,...

  • Regulatory Strategy Lead

    7 days ago

    Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time

    About This RoleThe Sr. Director Regulatory CMC will play a critical role in overseeing the development and implementation of global regulatory CMC strategies for assigned Spur global gene therapy programs. This position requires strategic and operational leadership for regulatory CMC activities, interfacing with CMC, Clinical, and Clin Reg teams.The ideal...

  • Senior Director Regulatory CMC Lead

    1 week ago

    Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time

    Spur Therapeutics: A Pioneer in Gene TherapyWe're at an inflection point in gene therapy, with emerging modalities pushing the boundaries of what's possible. As a Senior Director Regulatory CMC Lead at Spur Therapeutics, you'll play a crucial role in developing transformative adeno-associated virus (AAV) vector-mediated gene therapies.About the RoleThis...

  • Chief Regulatory Officer, Gene Therapy Development

    1 month ago

    Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time

    Spur Therapeutics: A Pioneer in Gene TherapyWe are a clinical-stage biotech company dedicated to developing innovative, one-time treatments for debilitating chronic diseases. Our integrated gene therapy platform includes research, protein engineering, and clinical development capabilities, allowing us to optimize every component of our product candidates and...

  • CMC Regulatory Manager

    1 month ago

    Stevenage, Hertfordshire, United Kingdom GSK Full time

    Opportunity OverviewGSK is a leading global biopharma company that has a bold ambition for patients: positively impacting the health of 2.5 billion people over the next 10 years.We are currently seeking a CMC Regulatory Manager to join our team in the UK. The successful candidate will have a strong background in regulatory affairs and experience in managing...

  • CMC Regulatory Strategy Manager

    2 weeks ago

    Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time

    We are seeking an experienced professional to join our team as a Senior Director Regulatory CMC Lead. This is a unique opportunity to be part of a pioneering company in the field of gene therapy. The successful candidate will have a strong scientific background and at least 10 years of experience in CMC regulatory disciplines in a pharmaceutical or biotech...

  • Global Regulatory Expert

    7 days ago

    Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time

    About the RoleSpur Therapeutics is a clinical-stage biotech company developing innovative gene therapies for patients worldwide.We are seeking a highly experienced Senior Director, CMC to oversee the development and implementation of global regulatory strategies for our assigned Spur global gene therapy programs.

  • Director of Regulatory Affairs

    2 weeks ago

    Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time

    Gene therapy is at a pivotal point. Amidst the plethora of emerging modalities, we've been refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives.About UsWe are a clinical-stage biotech company dedicated to developing...

  • CMC Strategic Leader

    7 days ago

    Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time

    Key ResponsibilitiesDevelop and implement global regulatory strategies for assigned Spur global gene therapy programsProvide strategic and operational leadership for regulatory CMC activities, interfacing with CMC, Clinical, and Clin Reg teamsEnsure timely and coordinated preparedness for Phase 3 program with aggressive timelines for enrollment and...

  • Regulatory Director, Gene Therapy Programs

    7 days ago

    Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time

    Key ResponsibilitiesThe successful candidate will be responsible for:Developing CMC regulatory strategies for Spur development-phase projectsCollaborating with cross-functional colleagues to ensure consistency of approach to CMC regulatory challenges across the portfolio/platformMaintaining an awareness of CMC regulatory guidance and intelligence and...

  • Senior Regulatory Affairs Strategist

    1 month ago

    Stevenage, Hertfordshire, United Kingdom GSK Full time

    About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Strategist to join our team at GSK. As a key member of our Regulatory Affairs department, you will play a critical role in shaping the development and implementation of our regulatory strategy for pharmaceutical products.This is an exciting opportunity for a talented individual with a...

  • Global Regulatory Affairs Director

    1 month ago

    Stevenage, Hertfordshire, United Kingdom GSK Full time

    Company OverviewGSK is a global biopharma company dedicated to unifying science, technology, and talent to get ahead of disease together. Our commitment is to positively impact the health of billions of people while delivering stronger, more sustainable shareholder returns.About the RoleWe are seeking a driven Global Regulatory Affairs Director to lead...

  • Manufacturing Process Specialist

    2 weeks ago

    Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time

    In this Sr. Scientist role, you will be instrumental in the set-up and handling of bioreactors and the development of scalable upstream manufacturing processes.About the Company:Spur Therapeutics is a global biotech company with research facilities and offices in the UK and the US. We are dedicated to developing transformative gene therapies for patients...