Senior Manager, Regulatory Affairs CMC

2 days ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time
Job Title: Senior Manager, Regulatory Affairs CMC

Job Summary:

The CMC Regulatory Affairs International Affiliate Team at Gilead Sciences International, Ltd. is seeking a highly skilled and experienced Senior Manager to join our team in Cambridge, United Kingdom. As a Senior Manager, Regulatory Affairs CMC, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to meet business objectives.

Key Responsibilities:
  • Ensure CMC regulatory submissions meet ICH and regional/local regulatory requirements.
  • Perform CMC regulatory submissions, including clinical trial applications, amendments, and marketing authorizations.
  • Collaborate with cross-functional teams to develop and implement regulatory strategies.
  • Provide regulatory intelligence and keep abreast of CMC registration requirements and best practices.
  • Contribute to local and global process improvements.
Requirements:
  • Scientific degree with directly relevant professional experience in CMC regulatory activities.
  • Practical knowledge of ICH and EU/UK CMC regulatory requirements.
  • Proven experience with submission compilation and filing of regulatory submissions.
  • Excellent communication and negotiation skills.
  • Ability to work independently and as part of a team.
What We Offer:

Gilead Sciences International, Ltd. is an equal opportunities employer and offers a competitive salary and benefits package.

  • Senior Manager Regulatory Affairs CMC

    1 day 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

    2 days 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 CMC Regulatory Affairs Manager

    1 month ago

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

    Opportunity at Gilead Sciences International, Ltd.Position OverviewThe CMC Regulatory Affairs International Affiliate Team is seeking a dedicated and knowledgeable Regulatory Affairs professional to join our ranks as a Senior Manager in CMC Regulatory Affairs. In this capacity, you will oversee CMC activities across the United Kingdom (UK).Role SummaryAs a...

  • Senior Manager, Regulatory Affairs CMC

    7 days 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

    7 days 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

    7 days 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

    7 days 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

    5 days 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

    5 days 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 weeks 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 developing, executing, and tracking regulatory CMC and medical device activities. Your expertise will be crucial in ensuring adherence to relevant regulatory requirements and collaborating with...

  • Senior Manager Regulatory Affairs CMC

    2 weeks 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 developing, executing, and tracking regulatory CMC and medical device activities. Your expertise will be crucial in ensuring adherence to relevant regulatory requirements and collaborating with...

  • Senior Manager Regulatory Affairs CMC

    15 hours 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.Develop and execute global regulatory CMC and device strategies and submissions, including CMC dossiers to...

  • Senior Manager Regulatory Affairs CMC

    1 day 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.Develop and execute global regulatory CMC and device strategies and submissions, including CMC dossiers to...

  • Senior Manager Regulatory Affairs CMC

    7 days 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

    7 days 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

    3 weeks ago

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

    Job SummaryWe are seeking a highly skilled and experienced Regulatory Affairs Senior Manager to join our team at Gilead Sciences International, Ltd. as a CMC Regulatory Affairs Manager. This is a full-time employment position in our Cambridge, UK office, reporting to the CMC Regulatory Affairs International Affiliate Team Leader.Key ResponsibilitiesEnsure...

  • Senior Manager, Regulatory Affairs CMC

    3 weeks ago

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

    Job SummaryWe are seeking a highly skilled and experienced Regulatory Affairs Senior Manager to join our team at Gilead Sciences International, Ltd. as a CMC Regulatory Affairs Manager. This is a full-time employment position in our Cambridge, UK office, reporting to the CMC Regulatory Affairs International Affiliate Team Leader.Key ResponsibilitiesEnsure...

  • Senior Manager, Regulatory Affairs CMC

    4 hours 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

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    About the RoleWe are seeking a highly skilled Senior Manager - Regulatory Affairs CMC to join our Clinical Development team at MoonLake Immunotherapeutics. 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 ResponsibilitiesDevelop and execute global regulatory...

  • Senior Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    About the RoleWe are seeking a highly skilled Senior Manager - Regulatory Affairs CMC to join our Clinical Development team at MoonLake Immunotherapeutics. 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 ResponsibilitiesDevelop and execute global regulatory...