Current jobs related to Senior Manager Regulatory Affairs CMC - Cambridge, Cambridgeshire - MoonLake Immunotherapeutics

  • CMC Regulatory Affairs Senior Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job OverviewGilead Sciences International, Ltd. is seeking a highly skilled Regulatory Affairs Senior Manager to join our team in the capacity of CMC Regulatory Affairs Senior Manager. This role will be based in Cambridge, United Kingdom and will report to the CMC Regulatory Affairs International Affiliate Team Leader.Key ResponsibilitiesEnsure CMC...

  • Senior Manager, Regulatory Affairs CMC

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gleeson Recruitment Group Full time

    Job Title: Senior Manager, Regulatory Affairs CMCA leading Biotech company in Cambridge is seeking a Senior Regulatory Affairs Manager CMC to join their team. The role will be responsible for the development, execution, and tracking of regulatory CMC activities.Key Responsibilities:Develop and execute global regulatory CMC and device strategies and...

  • Senior Manager, Regulatory Affairs CMC

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gleeson Recruitment Group Full time

    Job Title: Senior Manager, Regulatory Affairs CMCA leading Biotech company in Cambridge is seeking a Senior Regulatory Affairs Manager CMC to join their team. The role will be responsible for the development, execution, and tracking of regulatory CMC activities.Key Responsibilities:Develop and execute global regulatory CMC and device strategies and...

  • CMC Regulatory Affairs Senior Manager

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job Title: Senior Manager, Regulatory Affairs CMCAbout the Role: Gilead Sciences International, Ltd. is seeking a highly skilled and experienced Senior Manager, Regulatory Affairs CMC to join our team in Cambridge, United Kingdom. In this role, you will be responsible for ensuring CMC regulatory submissions meet ICH and regional/local regulatory...

  • Senior Manager, Regulatory Affairs CMC

    2 months ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job Title: Senior Manager, Regulatory Affairs CMCJob Summary:The CMC Regulatory Affairs International Affiliate Team at Gilead Sciences International, Ltd. is seeking a highly motivated and experienced Senior Manager to join our team in Cambridge, United Kingdom. As a key member of our Global CMC RA organization, you will serve as CMC RA Affiliate for...

  • Senior Manager, Regulatory Affairs CMC

    2 months ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job Title: Senior Manager, Regulatory Affairs CMCJob Summary:The CMC Regulatory Affairs International Affiliate Team at Gilead Sciences International, Ltd. is seeking a highly motivated and experienced Senior Manager to join our team in Cambridge, United Kingdom. As a key member of our Global CMC RA organization, you will serve as CMC RA Affiliate for...

  • Senior Manager, Regulatory Affairs CMC

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job Title: Senior Manager, Regulatory Affairs CMCJob Summary:The CMC Regulatory Affairs International Affiliate Team at Gilead Sciences International, Ltd. is seeking a highly motivated and experienced Senior Manager to join our team in Cambridge, United Kingdom. As a key member of our Global CMC RA organization, you will serve as CMC RA Affiliate for...

  • Senior Manager, Regulatory Affairs CMC

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job Title: Senior Manager, Regulatory Affairs CMCJob Summary:The CMC Regulatory Affairs International Affiliate Team at Gilead Sciences International, Ltd. is seeking a highly motivated and experienced Senior Manager to join our team in Cambridge, United Kingdom. As a key member of our Global CMC RA organization, you will serve as CMC RA Affiliate for...

  • Senior Manager Regulatory Affairs CMC

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job Title: Senior Manager Regulatory Affairs CMCMoonLake Immunotherapeutics is seeking a highly skilled Senior Manager Regulatory Affairs CMC to join our Clinical Development team. As a key member of our team, you will be responsible for the development, execution, and tracking of regulatory CMC and medical device activities.Key Responsibilities:Develop and...

  • CMC Regulatory Affairs Senior Manager

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job OverviewGilead Sciences International, Ltd. is seeking a highly skilled and experienced Regulatory Affairs Senior Manager to join our team in the capacity of CMC Regulatory Affairs Senior Manager. This role will be based in Cambridge, United Kingdom and will report to the CMC Regulatory Affairs International Affiliate Team Leader.Key...

  • Senior Manager, Regulatory Affairs CMC

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job Title: Senior Manager, Regulatory Affairs CMCJob Summary:The CMC Regulatory Affairs International Affiliate Team at Gilead Sciences International, Ltd. is seeking a highly motivated and experienced Senior Manager to join our team in Cambridge, United Kingdom. As a key member of our Global CMC RA organization, you will serve as CMC RA Affiliate for...

  • Senior Manager, Regulatory Affairs CMC

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job Title: Senior Manager, Regulatory Affairs CMCJob Summary:The CMC Regulatory Affairs International Affiliate Team at Gilead Sciences International, Ltd. is seeking a highly motivated and experienced Senior Manager to join our team in Cambridge, United Kingdom. As a key member of our Global CMC RA organization, you will serve as CMC RA Affiliate for...

  • Senior Manager Regulatory Affairs CMC

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job PurposeAs a Senior Manager, Regulatory Affairs CMC, you will play a pivotal role in MoonLake Immunotherapeutics' Clinical Development team, responsible for the development, execution, and tracking of regulatory CMC and medical device activities.You will be responsible for developing a CMC and device regulatory strategy, working closely with Technical...

  • Senior Manager Regulatory Affairs CMC

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job PurposeAs a Senior Manager, Regulatory Affairs CMC, you will play a pivotal role in MoonLake Immunotherapeutics' Clinical Development team, responsible for the development, execution, and tracking of regulatory CMC and medical device activities.You will be responsible for developing a CMC and device regulatory strategy, working closely with Technical...

  • CMC Regulatory Affairs Senior Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job Title: CMC Regulatory Affairs Senior ManagerJob Summary:Gilead Sciences International, Ltd. is seeking a highly skilled CMC Regulatory Affairs Senior Manager to join our team. As a key member of our Global CMC RA organization, you will serve as a CMC RA Affiliate for assigned products and territories, designing and executing CMC RA strategies that align...

  • Senior Manager, Regulatory Affairs CMC

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job Title: Senior Manager, Regulatory Affairs CMCDescriptionThe CMC Regulatory Affairs International Affiliate Team at Gilead Sciences International, Ltd. is seeking a highly motivated and experienced Regulatory professional to assume a full-time employment position in our office in Cambridge, United Kingdom. As a Senior Manager, Regulatory Affairs CMC, you...

  • Senior Manager, Regulatory Affairs CMC

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job Title: Senior Manager, Regulatory Affairs CMCDescriptionThe CMC Regulatory Affairs International Affiliate Team at Gilead Sciences International, Ltd. is seeking a highly motivated and experienced Regulatory professional to assume a full-time employment position in our office in Cambridge, United Kingdom. As a Senior Manager, Regulatory Affairs CMC, you...

  • Senior Manager, Regulatory Affairs CMC

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job Title: Senior Manager, Regulatory Affairs CMCDescriptionThe CMC Regulatory Affairs International Affiliate Team at Gilead Sciences International, Ltd. is seeking a highly motivated and experienced Regulatory professional to assume a full-time employment position in our office in Cambridge, United Kingdom. As a Senior Manager, Regulatory Affairs CMC, you...

  • Senior Manager, Regulatory Affairs CMC

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job Title: Senior Manager, Regulatory Affairs CMCDescriptionThe CMC Regulatory Affairs International Affiliate Team at Gilead Sciences International, Ltd. is seeking a highly motivated and experienced Regulatory professional to assume a full-time employment position in our office in Cambridge, United Kingdom. As a Senior Manager, Regulatory Affairs CMC, you...

  • Senior Manager Regulatory Affairs CMC

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    {"h1": "Senior Manager Regulatory Affairs CMC", "p": "As a key member of MoonLake Immunotherapeutics\u2019 Clinical Development team, you will be responsible for the development, execution, and tracking of regulatory CMC and medical device activities. Your expertise will be crucial in ensuring adherence to relevant regulatory requirements and collaborating...

Senior Manager Regulatory Affairs CMC

1 month ago

Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time
{"h3": "Job Overview"}

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company seeking a highly skilled Senior Manager Regulatory Affairs CMC to join our team. As a key member of our Clinical Development team, you will be responsible for developing, executing, and tracking regulatory CMC and medical device activities.

{"h3": "Key Responsibilities"}
  • Develop and execute 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, such as Module 3 IND, IMPD, amendments, and annual reports.
  • Develop and maintain 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.
{"h3": "Requirements"}
  • Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred.
  • 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.
{"h3": "What We Offer"}
  • An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.
  • 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.
  • A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.
{"h3": "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 headquartered in Zug, with hubs in Cambridge & Porto.

Further information is available at www.moonlaketx.com