Senior Reporting Manager

3 weeks ago


Cambridge Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

As an Associate Director, Regulatory Affairs, you are an integral part of MoonLake’s team and will be responsible for developing and delivering innovative global regulatory strategies for sonelokimab lead indication(s).
You will be responsible for regulatory aspects related to product development and approval, in alignment with the global business strategy and in partnership with the functional subject matter experts within MoonLake.
Work with functional colleagues and project teams to develop and implement regulatory strategies enable earliest possible approval, in line with business objectives.
Support interactions with global regulatory interactions to facilitate approval of all regulatory submissions for sonelokimab.
Coordinate the preparation, review and submission of regulatory dossiers to support clinical studies, marketing applications and scientific advice.
Coordinate appropriate responses to regulatory agency questions with relevant colleagues.
Identification and assessment of regulatory risks and implementation of strategies to minimize risks.
Provide expert advice to internal teams on regulatory issues as they arise.
Ensure up-to-date knowledge with regard to guidelines and regulatory trends.
Maintain a thorough knowledge of specific diseases, including a detailed understanding of competitor activities and the prevailing medical practice.
Lead/support the development of processes, SOPs and other controlled documents, including for Regulatory Affairs activities.
Partner with Regulatory Affairs and cross-functional colleagues to understand the regulatory landscape, e.g. regulatory precedents, labeling differences and adapts to changes that may impact MoonLake development programs.
PhD or Masters) preferred.

Minimum of 7 years of experience within regulatory affairs in pharmaceutical industry/Biotech industry, ideally in a relevant disease area.
Experience in working globally and dealing with FDA and/or EMA and national health authorities, from clinical development programs to marketing authorization and scientific advice.

Ability to create and implement innovative regulatory strategies.
Good knowledge of the drug development lifecycle and regulatory requirements from clinical trials to marketing is required.
Adaptable with the ability to generate creative solutions, identify different and novel ways to find solutions, and adapt to changing priorities and deadlines.
Highly collaborative, strong relationship building skills with internal and external partners, with a high level of integrity.
An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.
Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.
Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.
Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.
We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.
We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.
We aspire to create long-term value for investors and communities.
#



  • Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Hays is seeking a Senior Manager of Associate Director for a top tier UK wealth management and professionals' services group. Known for their growth and innovation, our client values integrity and excellence, ensuring they employ the best talent. Their Cambridge office is on a significant growth trajectory and needs a motivated Tax Senior Manager or...

  • Senior Tax Manager

    3 weeks ago


    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Hays is seeking a Senior Manager of Associate Director for a top tier UK wealth management and professionals' services group. Known for their growth and innovation, our client values integrity and excellence, ensuring they employ the best talent. Their Cambridge office is on a significant growth trajectory and needs a motivated Tax Senior Manager or...

  • Reporting Manager

    1 week ago


    Cambridgeshire, United Kingdom Pure Resourcing Solutions Limited Full time

    Excellent opportunity for a qualified accountant to join a lovely team and business located North of Cambridge and within easy reach of Peterborough and Cambridge.  The Reporting Manager is responsible for global internal controls and US-GAAP compliance. The role drives best financial practices and manages SOX compliance and tax. The position also plays a...


  • Cambridge, Cambridgeshire, United Kingdom EA First Full time

    Job Title: Senior Reporting Business ProfessionalA senior-level position requiring an experienced professional to provide advanced business analysis and reporting expertise.The successful candidate will be responsible for analyzing and documenting financial reporting systems, collaborating with cross-functional teams to drive reporting initiatives, and...


  • Cambridge, Cambridgeshire, United Kingdom KOS International Limited Full time

    Our client, a global cryptocurrency trading and asset management platform with a newly established UK office in Cambridge, is seeking a senior Compliance Manager to responsible for ensuring that the company's operations comply with regulatory requirements and internal policies, safeguarding the legality and standardization of business activities. Oversee...


  • Cambridge, Cambridgeshire, United Kingdom KOS International Limited Full time

    Our client, a global cryptocurrency trading and asset management platform with a newly established UK office in Cambridge, is seeking a senior Compliance Manager to responsible for ensuring that the company's operations comply with regulatory requirements and internal policies, safeguarding the legality and standardization of business activities. Oversee...

  • Accounting Manager

    2 weeks ago


    Cambridge, Cambridgeshire, United Kingdom Austin Fraser Full time

    Austin Fraser is seeking an experienced Accounting Manager to join our team. In this role, you will be responsible for leading senior audit engagements and managing audit teams, as well as providing financial accounting support to the transactional team and preparing statutory reports to group.About the RoleThe ideal candidate will have a strong background...


  • Cambridge, Cambridgeshire, United Kingdom Hays Full time

    Our client, a multinational semiconductor and software design company seeks a Data & Insights Manager for a 6 month initially contract initially to start in January, based in Cambridge ( Hybrid), Inside IR35, up to £650 per day. Are you able to shape the way an organisation captures and utilises its data to inspire change? We are seeking an innovative...


  • Cambridge, Cambridgeshire, United Kingdom Hays Full time

    Our client, a multinational semiconductor and software design company seeks a Data & Insights Manager for a 6 month initially contract initially to start in January, based in Cambridge ( Hybrid), Inside IR35, up to £650 per day. Are you able to shape the way an organisation captures and utilises its data to inspire change? We are seeking an innovative...

  • Reporting Manager

    1 week ago


    Cambridge, United Kingdom Pure Resourcing Solutions Limited Full time

    Excellent opportunity for a qualified accountant to join a lovely team and business located North of Cambridge and within easy reach of Peterborough and Cambridge.  The Reporting Manager is responsible for global internal controls and US-GAAP compliance. The role drives best financial practices and manages SOX compliance and tax. The position also plays a...


  • Cambridge, Cambridgeshire, United Kingdom KOS International Limited Full time

    Our client, a global cryptocurrency trading and asset management platform with a newly established UK office in Cambridge, is seeking a senior Compliance Manager to responsible for ensuring that the company's operations comply with regulatory requirements and internal policies, safeguarding the legality and standardization of business activities. Key...


  • Cambridge, Cambridgeshire, United Kingdom KOS International Limited Full time

    Our client, a global cryptocurrency trading and asset management platform with a newly established UK office in Cambridge, is seeking a senior Compliance Manager to responsible for ensuring that the company's operations comply with regulatory requirements and internal policies, safeguarding the legality and standardization of business activities. Key...


  • Cambridge, United Kingdom RSM Full time

    Financial Reporting Training Manager AtRSM, we want training to be more than just a transfer of knowledge. Training is a vital ingredient of everyindividual’s development. It is highlyvalued and respected by the business. Toearn that respect, we design our courses in collaboration with the business toensure we meet their needs. We are constantly...


  • Cambridge, Cambridgeshire, United Kingdom Turner & Townsend Group Full time

    That means delivering better outcomes for our clients, helping our people to realize their potential, and doing our part to create a prosperous society. Every day we help our major global clients deliver ambitious and highly technical projects, in over 110 offices worldwide. We are seeking an experienced Senior Project Manager to join our Real Estate...


  • Cambridge, Cambridgeshire, United Kingdom EA First Compass House Full time

    Job DescriptionWe are seeking a highly skilled Accounting and Reporting Specialist to join our team at EA First Compass House. As a key member of our finance department, you will be responsible for managing the day-to-day aspects of the Finance Function.Main AccountabilitiesFinancial Reporting: Develop and maintain accurate financial reports for senior...


  • Cambridge, Cambridgeshire, United Kingdom Venn Group Full time

    Venn Group's client in Cambridgeshire is looking for a talented Financial Reporting Expert to join their finance team. As a key member of the team, you will play a crucial role in producing accurate financial reports and ensuring the smooth operation of the finance function.The ideal candidate will have extensive experience in financial reporting, including...


  • Cambridge, Cambridgeshire, United Kingdom BWX Technologies, Inc. Full time

    Estimated Salary: $130,000 - $160,000 per annumThe Senior Financial Reporting Analyst role at BWX Technologies, Inc. offers a unique opportunity to leverage your financial expertise and contribute to the success of our company. In this position, you will play a critical role in analyzing and interpreting financial data, preparing financial reports, and...


  • Cambridge, Cambridgeshire, United Kingdom Elby Professional Recruitment Full time

    Our client is looking for a highly skilled Management Reporting Analyst to join their team.In this on-site position, you will work closely with the executive team to analyze and prepare financial statements, forecasts, and other financial reports. You will also develop and implement financial models to support business decision-making.The successful...


  • Cambridge, Cambridgeshire, United Kingdom EA First Full time

    We are seeking a skilled accountant to join our team as a Financial Reporting Manager in a dynamic SaaS organisation. In this varied role, you will work closely with the Group Controller to provide group-wide financial reports and analysis.This is a broad role where your responsibilities will include:Management of fortnightly revenue forecast, quarterly full...


  • Cambridge, Cambridgeshire, United Kingdom IC Resources Full time €65,000 - €75,000

    Are you a Senior Project Manager looking to take your career to the next level? If so, this Senior Project Manager role is your opportunity to make an impact on groundbreaking projects in the quantum technology sector. As a Senior Project Manager, you’ll work closely with a talented team of engineers and researchers to deliver cutting-edge projects that...