Regulatory Affairs Lead

6 months ago

London, United Kingdom Spark Therapeutics Full time

Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation.

We don’t follow footsteps. We create the path.

**Primary Duties**

The Director, Regulatory Affairs will collaborate with other Regulatory Affairs & Patient Safety leaders as necessary to support the build of appropriate EU/International infrastructure relevant for developing regulatory policy and intelligence activities in the EU/International region.

**Responsibilities**
- Lead interactions with regulatory agencies in the given region at both national and central level and lead internal teams in navigating such interactions.
- Serve as a resource for EU/International knowledge for the global clinical development organization.
- Monitor emerging legislation and guidance in the given region and contribute to ensuring company-level awareness and compliance (where appropriate).
- Serve as Spark regulatory representative for the assigned program(s).
- Lead the regulatory submissions (ODDs, PIPs, CTAs etc.) relevant to assigned programs, in accordance with submission and approval requirements. Lead functional groups across the organization in the development of relevant data to complete regulatory submissions.
- Provide regulatory input to market access strategy and HTA plans and submissions in the EU/International region.
- Ensure QP requirements and local regulatory requirements are fulfilled for each country as necessary.
- Respond to objections/questions issued by Regulatory Authorities/Agencies.
- Lead Spark response to objections/questions issued by EU/International Regulatory Authorities/Agencies.
- Lead the preparation, submission and follow-up of Orphan Drug Applications, Pediatric Study Plans, Pediatric Investigational Plans, etc.
- Report adverse events and other unanticipated problems to EU regulatory agencies and internal stakeholders.
- Responsible for accuracy and content of communications
- Lead the preparation, review, and approval of compliant regulatory documents throughout the product lifecycle.
- Provide EU regulatory guidance to cross-functional teams for project and product lifecycle planning.
- Anticipate regulatory obstacles and emerging issues, including changing regulations, throughout the product lifecycle and develop solutions with other members of regulatory and cross-functional teams.
- Work effectively with regulatory colleagues specializing in other functional areas to continuously improve regulatory systems, teamwork, and efficiency.
- Evaluate proposed nonclinical, clinical, and manufacturing changes for regulatory filing strategies.
- Manage and execute pre-approval and post-marketing compliance activities.
- Lead the development & implementation of EU regulatory policies, processes, systems, and SOPs and train key personnel on them.
- Contribute to the development of relevant networks with Roche colleagues to support the ongoing build of regulatory policy and intelligence activities/interactions for the EU/International region.
- Support and contribute to the development of Spark global regulatory strategies to advance Spark products through the regulatory review and approval process globally.
- Actively contribute to the development and implementation of regulatory processes for multi-country trials.
- Other program-related tasks and duties as may be required.

**Education and Experience Requirements**
- Degree in life science, e.g., Pharmacy, Biology or Chemistry required. PhD or other advanced scientific degrees strongly preferred.
- Generally, has 10+ years related experience (e.g., healthcare, and/or clinical research experience), with at least 8 years of direct regulatory experience.
- Experience of directly working with the EMA and national regulatory agencies and leading agency meetings face to face.
- Experience of bringing a product through EU approval is a distinct advantage.
- Experience working with novel drug therapies and orphan product is preferred.
- Current knowledge and understanding of GxPs (GCPs, GLPs, GMPs) and ICH guidelines as well as EMA, FDA, international, and, if applicable, local regulations.

**Key Skills, Abilities, and Competencies**
- Ability to negotiate and concisely express clear positions to stakeholders at all levels.
- Excellent written and verbal communication skills.
- Thorough knowledge of the drug development process, with a focus on CTA and MAA/NDA/BLA processes.
- Excellent writing skills with an ability to write detailed information for submissions.
- Excellent ability to read, analyze and interpret technical documents, technical procedures and government regulations.
- Prepare and deliver effective presentations for external and internal audiences.
- Knowledge of computers and appropriate software packages. Experience with electronic submissions preferred.
- Ability to h

  • Regulatory Affairs Director

    6 days ago

    London, Greater London, United Kingdom Regulatory Affairs Professionals Society Full time

    OverviewWe are seeking a highly skilled Regulatory Affairs Manager to join our team at the Regulatory Affairs Professionals Society. As a key member of our organization, you will be responsible for overseeing regulatory strategy and ensuring compliance within our ingredient agent, brokerage, and solution manufacturing businesses.

  • Regulatory Affairs Manager

    1 month ago

    London, Greater London, United Kingdom Turner Regulatory Full time

    Regulatory Affairs ManagerTurner Regulatory is seeking a highly skilled Regulatory Affairs Manager to join our team. The successful candidate will have a background in European Market Regulatory activity and excellent commercial awareness.Key Responsibilities:Liaise closely with Business Development, Regulatory Science, Pharmacovigilance, Product Launch,...

  • Regulatory Affairs Strategist

    6 days ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Role OverviewA challenging opportunity has arisen for a Regulatory Affairs Strategist to join VRS Regulatory's team. About the RoleWe are seeking an experienced Regulatory Affairs Strategist to develop and implement regulatory strategies for plant protection products in specific geographical territories. Develop and execute regulatory strategies for product...

  • Regulatory Affairs Strategist

    3 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Job DescriptionAs a Regulatory Affairs Specialist at VRS Regulatory, you will have the opportunity to develop and implement regulatory strategies for plant protection products in specific geographical territories. Your key responsibilities will include managing a portfolio of plant protection products, developing regulatory submissions, and working with the...

  • Food Safety Regulatory Manager

    1 day ago

    London, Greater London, United Kingdom Regulatory Affairs Professionals Society Full time

    About the RoleWe are seeking an experienced Regulatory Affairs professional to join our team as a Regulatory Affairs Manager. As a key member of our regulatory affairs team, you will play a critical role in ensuring that our products comply with all relevant regulations and legislation.Your primary responsibility will be to develop and implement regulatory...

  • Regulatory Affairs Specialist

    4 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    An exciting opportunity to lead regulatory strategy for plant protection products has become available within VRS Regulatory.As a Regulatory Affairs Specialist, you will be responsible for developing and implementing regulatory strategies for our product portfolio in specific geographical territories. This will involve managing a portfolio of plant...

  • Regulatory Affairs Specialist

    4 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Career OpportunityVRS Regulatory is seeking a highly skilled Regulatory Affairs Specialist to join our team in delivering regulatory services related to chemistry and analytical methods for plant protection products.Key Responsibilities:Provide regulatory advice to clients on substance and product registrations strategies.Review phys-chem...

  • Regulatory Compliance Specialist

    1 day ago

    London, Greater London, United Kingdom Regulatory Affairs Professionals Society Full time

    Job DescriptionAs a Regulatory Affairs Manager at Prinova Europe, you will oversee regulatory strategy for the organisation, providing leadership and guidance to the business on regulatory matters for food, feed and personal care activity in the UK and other markets where Prinova Europe and Prinova Solutions Europe operates.This role involves ensuring...

  • Chemistry and Analytical Methods Regulatory Affairs Expert

    6 days ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Established chemical regulatory science consultancy is seeking a delivery-focused Regulatory Affairs Specialist to cover an increasing workload.This role will take the lead on physical/chemical properties/analytical methods and method validation for plant protection products. Key responsibilities include:Providing clients with regulatory advice on substance...

  • Regulatory Affairs Lead

    6 days ago

    London, Greater London, United Kingdom Advanced Accelerator Applications (Italy) - S... Full time

    Job TitleRegulatory Affairs Lead (#J-18808-Ljbffr)About the CompanyAdvanced Accelerator Applications (Italy) - S...Job DescriptionThe Senior Regulatory Affairs Manager is a key member of our team, responsible for all aspects of submission, approval and life-cycle management of assigned Marketing Authorisations (MAs). They provide effective regulatory support...

  • Sds Author

    6 months ago

    London, United Kingdom VRS Regulatory Full time

    We are looking for a Safety Data Sheet / SDS Author / Regulatory Officer for a London based consumer products company. Your role will be varied and include researching pending changes developments to global chemical regulations, developing regulatory documents (SDSs, labels etc) for new and existing products, and providing regulatory support to internal...

  • Regulatory Affairs Director

    1 month ago

    London, Greater London, United Kingdom Reed Specialist Recruitment Ltd Full time

    Regulatory Affairs ManagerReed Specialist Recruitment Ltd is seeking an experienced Regulatory Affairs Manager to oversee and manage the regulatory affairs team for a global healthcare provider based in the North West of the UK.Main Responsibilities:Regulatory Strategy: Develop and implement regulatory strategies aligned with the company's strategic...

  • Senior Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom Medicines and Healthcare products Regulatory Agency Full time

    We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at the Medicines and Healthcare products Regulatory Agency. This is a full-time opportunity, on a permanent basis, and requires a minimum of 8 days per month working on site to enable collaboration and contact with partners and stakeholders.The Pharmacovigilance Policy Lead...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom BTA Full time

    At BTA, we are seeking a highly skilled Regulatory Affairs Specialist to join our International Regulatory Affairs Team in London, UK.The successful candidate will be responsible for providing regulatory support for development programs or marketed products, contributing to the development of regulatory strategies for development and commercialization of...

  • Regulatory Affairs Specialist

    4 weeks ago

    London, Greater London, United Kingdom Warman O'Brien Full time

    Job Title: Regulatory Affairs SpecialistJob Description:Warman O'Brien is seeking a Regulatory Affairs Specialist to join their team. As a Regulatory Affairs Specialist, you will be responsible for compiling, preparing, and submitting relevant components of the dossier, leading agency interactions, and advising on regulatory...

  • Regulatory Affairs Expert

    1 month ago

    London, Greater London, United Kingdom Warman O'Brien Full time

    Job Title: Senior Regulatory Affairs ManagerJob Description:Warman O'Brien is seeking a Senior Regulatory Affairs Manager to join their team. As a key member of the regulatory affairs team, you will be responsible for ensuring compliance with relevant legislation and regulations.Key Responsibilities:Compiling and submitting relevant components of the...

  • Regulatory Affairs Lead for UK and Ireland

    6 days ago

    London, Greater London, United Kingdom Ferring Pharmaceuticals Full time

    Job Title: Regulatory Affairs Lead for UK and IrelandFerring Pharmaceuticals is a global pharmaceutical company that aims to improve the lives of people around the world.We are currently seeking an experienced Regulatory Affairs Lead to join our team in the UK and Ireland. As a key member of our regulatory affairs team, you will be responsible for developing...

  • Regulatory Affairs Manager

    3 weeks ago

    London, United Kingdom Warman O'Brien Full time

    Regulatory Affairs Manager Warman O'Brien are searching for a Regulatory Affairs Manager for a globally renowned pharmaceutical business that manufactures Generic products in the UK. The role has arisen due to an increase in workload as the team looks to expand in the UK. This is a hybrid role with an expectation of 2-3 days per week in office. ...

  • Regulatory Affairs Manager

    1 month ago

    London,, UK, United Kingdom Warman O'Brien Full time

    Regulatory Affairs ManagerWarman O'Brien are searching for a Regulatory Affairs Manager for a globally renowned pharmaceutical business that manufactures Generic products in the UK.The role has arisen due to an increase in workload as the team looks to expand in the UK.This is a hybrid role with an expectation of 2-3 days per week in office.Regulatory...

  • Regulatory Affairs Manager

    3 weeks ago

    London, United Kingdom Warman O'Brien Full time

    Regulatory Affairs ManagerWarman O'Brien are searching for a Regulatory Affairs Manager for a globally renowned pharmaceutical business that manufactures Generic products in the UK.The role has arisen due to an increase in workload as the team looks to expand in the UK.This is a hybrid role with an expectation of 2-3 days per week in office.Regulatory...