Senior Manager

5 months ago

Cambridge, United Kingdom MoonLake Immunotherapeutics Full time
Job Purpose

As a Senior Manager, Regulatory Affairs CMC, you are an integral part of MoonLake’s Clinical Development team responsible for the development, execution and tracking of regulatory CMC and medical device activities.
You will be responsible for the development of a CMC and device regulatory strategy, working closely with Technical Operations colleagues. The Senior Manager, Regulatory Affairs CMC will serve as a subject matter expert, which will involve collaborating with multiple internal and external partners and will ensure adherence to relevant regulatory requirements.

Key Responsibilities:

  • Responsible for the development and execution of global regulatory CMC and device strategies and submissions, including CMC dossiers to support clinical trial applications and marketing applications
  • Collaborate with internal Technical Operations colleagues and external organizations to develop submission content plans and timelines and support the timely execution of regulatory submissions that require CMC content, responses to questions, audits and inspections
  • Manage the preparation, drafting, review, risk analysis and mitigation planning of CMC submissions e.g. Module 3 IND, IMPD, amendments and annual reports
  • Developing and maintaining internal cross-functional relationships to support the development and execution of CMC regulatory submissions
  • Responsible for the regulatory assessment of change controls, maintenance of regulatory files and tracking databases related to CMC submissions
  • Lead/support the development of processes, SOPs and other controlled documents, including for Regulatory Affairs activities
Partners with Regulatory Affairs and cross-functional colleagues to understand the CMC regulatory landscape, e.g. regulatory precedents, labeling differences and other CMC-specific issues and adapts to changes that may impact MoonLake development programsYour profile

Education:

  • Minimum of first degree in life sciences (or equivalent); advanced degree (e.g. PhD or Masters) preferred. 
Experience:
 
  • Experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry
  • Experience and knowledge in preparation of CMC sections of INDs, CTAs, and marketing applications is required
  • Working knowledge of FDA, EMA, ICH and cGMP CMC regulatory guidance and regulations
  • Experience working with recombinant proteins is highly desirable
  • Experience interactions with health authorities such as scientific advice or agency meetings, including with FDA, is desirable
 
Skills/knowledge/behavioural competencies:
 
  • An understanding of the drug development lifecycle from clinical trials to marketing is required
  • Ability to understand and clearly communicate on topics of basic science is essential
  • Ability to proactively identify risks and develop risk mitigation strategies
  • 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
  • Works proactively using solid communication and influencing skills to effectively execute program goals
  • Works effectively in a highly complex and fast-paced environment
Why us?

An exciting job opportunity awaits
MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.

What we offer:

Learning Environment: 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.

Flexibility and Balance: 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.

Our Core Values

We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence: 

We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.

We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.

We unlock value: We aspire to create long-term value for investors and communities.

About us

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of the inflammatory disease, to revolutionize outcomes for patients.

We continue to make significant progress in our Global Clinical Development Programs. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquarted in Zug, with hubs in Cambridge & Porto.

Further information is available at www.moonlaketx.com

  • Senior Tax Manager

    4 days ago

    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Job Title: Senior Tax ManagerHays Senior Finance is seeking a highly skilled Senior Tax Manager to join our team in Cambridge. As a Senior Tax Manager, you will be responsible for managing a portfolio of corporate compliance clients and working closely with shareholders and founders of OMB's on advisory work.Key Responsibilities:Business development of...

  • Senior Tax Manager

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Job Title: Senior Tax ManagerHays Senior Finance is seeking a highly skilled Senior Tax Manager to join our team in Cambridge. As a Senior Tax Manager, you will be responsible for providing expert tax advice to our clients and managing a portfolio of corporate compliance clients.Key Responsibilities:Develop and implement tax strategies for clientsManage a...

  • Senior Tax Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Job Title: Senior Tax ManagerJob Summary:We are seeking a highly skilled Senior Tax Manager to join our team at Hays Senior Finance. As a Senior Tax Manager, you will be responsible for providing expert tax advice to our clients and managing a portfolio of corporate compliance clients.Key Responsibilities:Develop and implement tax strategies for clients to...

  • Senior Tax Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Job Title: Senior Tax ManagerJob Summary:We are seeking a highly skilled Senior Tax Manager to join our team at Hays Senior Finance. As a Senior Tax Manager, you will be responsible for providing expert tax advice to our clients and managing a portfolio of corporate compliance clients.Key Responsibilities:Develop and implement tax strategies for clients to...

  • Senior Tax Manager

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Job Title: Senior Tax ManagerAbout the Role:We are seeking a highly skilled Senior Tax Manager to join our team at Hays Senior Finance. As a Senior Tax Manager, you will be responsible for providing expert tax advice to our clients and managing a portfolio of corporate compliance clients.Key Responsibilities:Develop and implement tax strategies for...

  • Senior Tax Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Job Title: Senior Tax ManagerHays Senior Finance is seeking a highly skilled Senior Tax Manager to join our team in Cambridge. As a Senior Tax Manager, you will be responsible for providing expert tax advice to clients and managing a portfolio of corporate compliance clients.Key Responsibilities:Develop and implement tax strategies for clients to minimize...

  • Senior Tax Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Job Title: Senior Tax ManagerHays Senior Finance is seeking a highly skilled Senior Tax Manager to join our team in Cambridge. As a Senior Tax Manager, you will be responsible for providing expert tax advice to clients and managing a portfolio of corporate compliance clients.Key Responsibilities:Develop and implement tax strategies for clients to minimize...

  • Senior Tax Manager

    4 days ago

    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Hays Senior Finance is recruiting a Senior Manager for one of the UK's leading integrated wealth management and professional services group.Our client has an exceptional track record of growth and innovation, driven by their core values and the best people they employ. The Cambridge office is on an ambitious growth journey, requiring a driven and ambitious...

  • Senior Tax Manager

    20 hours ago

    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    About the RoleHays Senior Finance is recruiting a Senior Tax Manager for one of the UK's leading integrated wealth management and professional services group. Our client has an exceptional track record of growth and innovation and is looking for a driven and ambitious Tax Senior Manager to join their dynamic team in Cambridge.Key ResponsibilitiesYou will be...

  • Senior Tax Manager

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Job SummaryWe are seeking a highly skilled Senior Tax Manager to join our team at Hays Senior Finance. As a Senior Tax Manager, you will be responsible for providing tax services to our business owners, including preparing partner tax returns, computation of LLP tax return, and offering tax advice and support to partners.Key ResponsibilitiesPrepare and...

  • Senior Tax Manager

    4 days 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.Job DescriptionYou will be involved in business development of existing and new clients as well as potentially...

  • Senior Tax Manager

    2 weeks ago

    Cambridge, United Kingdom Hays Senior Finance Full time

    Senior Tax Manager Employer Location Cambridgeshire, England, Cambridge Salary Highly competitive + benefits Closing date 13 Nov 2024 View more categoriesView less categories Sector Salary band , , , , Contract type Hours Where will they be working You need to or to save a job. Job Details Hays are recruiting a Senior Manager for one of the UK's...

  • Senior Tax Manager or Associate Director

    7 days ago

    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Job DetailsHays Senior Finance is seeking a highly skilled Tax Senior Manager or Associate Director to join their dynamic team in Cambridge. As a key member of the team, you will be responsible for business development, advisory work, and managing a portfolio of corporate compliance clients.Key Responsibilities:Develop and implement business development...

  • Senior Tax Manager or Associate Director

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Job DetailsHays Senior Finance is seeking a Senior Tax Manager or Associate Director to join their Cambridge office. This is a fantastic opportunity for a motivated and ambitious tax professional to lead a dynamic team and contribute to the company's growth and innovation.Key ResponsibilitiesBusiness development of existing and new clients, including...

  • Senior Tax Manager or Associate Director

    4 days ago

    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Job DetailsHays Senior Finance is seeking a highly skilled Tax Senior Manager or Associate Director to join their dynamic team in Cambridge. As a key member of the team, you will be responsible for business development, advisory work, and managing a portfolio of corporate compliance clients.Key ResponsibilitiesDevelop and implement business development...

  • Senior Tax Manager or Associate Director

    5 days ago

    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Job DetailsHays Senior Finance is seeking a Senior Tax Manager or Associate Director to join their dynamic team in Cambridge. This is an excellent opportunity for a motivated and experienced tax professional to lead and contribute to the growth of the company.Key ResponsibilitiesDevelop business relationships with existing and new clients, and develop...

  • Senior Tax Manager or Associate Director

    2 weeks ago

    Cambridge, United Kingdom Hays Senior Finance Full time

    Senior Tax Manager or Associate Director Employer Location England, Cambridgeshire, Cambridge Salary Highly competitive + benefits Closing date 19 Nov 2024 View more categoriesView less categories Sector Salary band , , , , Contract type Hours Where will they be working You need to or to save a job. Job Details Hays is seeking a Senior Manager...

  • Tax Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Job Title: Partnership Tax Senior Manager or ManagerJob Summary:We are seeking an experienced Partnership Tax Senior Manager or Manager to join our team at Hays Senior Finance. As a key member of our tax team, you will be responsible for providing tax services to our business owners, including preparing partner tax returns, computation of LLP tax return, and...

  • Tax Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Job Title: Partnership Tax Senior Manager or ManagerJob Summary:We are seeking an experienced Partnership Tax Senior Manager or Manager to join our team at Hays Senior Finance. As a key member of our tax team, you will be responsible for providing tax services to our business owners, including preparing partner tax returns, computation of LLP tax return, and...

  • Tax Manager

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Job Title: Partnership Tax Senior Manager or ManagerJob Summary:We are seeking an experienced Partnership Tax Senior Manager or Manager to join our team at Hays Senior Finance. As a key member of our tax team, you will be responsible for providing tax services to our business owners, including preparing partner tax returns, computation of LLP tax return, and...