Regulatory Affairs Associate Ii

7 months ago


Cambridge, United Kingdom Proclinical Full time

Proclinical are recruiting for a Regulatory Affairs Associate II to join a pharmaceutical organisation. This role is on a contract basis and is located in Cambridge/Uxbridge with hybrid working available.

**Key Skills and Requirements**:

- Administration familiarity within a corporate or similar business setting, preferably within a healthcare sector.
- Educated to a degree level in a scientific field would be ideal.
- Demonstrable experience in regulatory CTA linked tasks assisting medicinal products.
- Familiarity writing or updating processes is desirable.
- Capable of learning swiftly and being flexible and adaptable to change.
- Expertise on regulatory CTA needs and the role of regulatory affairs as these pertain medicinal product clinical trials, which involves expertise and comprehension of ICH standards and varying regional needs in the allocated markets.
- An organised individual with a high attention to detail.
- Computer literacy.
- Project management capabilities with the capacity to handle and complete various assignments concurrently.
- Communication skills both verbally and in writing as well as in a clear and concise manner.
- Works well in a team-focused, highly matrixed work setting.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

Regulatory



  • Cambridge, United Kingdom Proclinical Full time

    Proclinical are recruiting for a Regulatory Affairs Associate - II to join a pharmaceutical organisation. This role is on a contract basis and is located in either Cambridge or Uxbridge with hybrid working available. **Responsibilities**: - Conduct workflows and processes concerning document tracking, indexing, retrieving, and disseminating information to...


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

    Job SummaryGilead Sciences International, Ltd. is seeking an experienced Regulatory Affairs Associate Director to join our Global Regulatory Affairs team. The successful candidate will be responsible for providing oversight and management of regulatory activities provided by Gilead's in-market partners in the Gilead Patient Solutions (GPS) region.The ideal...


  • Cambridge, United Kingdom Bicycle Therapeutics Full time

    Job DescriptionThe Senior Associate, Regulatory Affairs will be responsible for the development, execution and tracking of regulatory activities for assigned BicycleTx programs or projects.The Senior Associate, Regulatory Affairs may also be responsible for supporting the development of regulatory strategy and processes for their assigned BicycleTx programs...


  • Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time £85,000 - £110,000

    Associate Director, Regulatory AffairsCpl Life Sciences is seeking an experienced Associate Director, Regulatory Affairs to join our team. This is a permanent, full-time opportunity based in Cambridge, UK, with a hybrid/remote work arrangement.About the RoleWe are looking for a highly skilled and motivated individual to lead our regulatory affairs strategy...


  • Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time

    Job Title: Associate Director, Regulatory AffairsJob Type: Permanent, full-timeLocations: Cambridge, UK – Hybrid/RemoteRemuneration: £85,000 - £110,000 + benefitsCpl Life Sciences is seeking a highly skilled Regulatory Affairs professional to lead strategy for development programs globally. As an Associate Director, Regulatory Affairs, you will support...


  • Cambridge, Cambridgeshire, United Kingdom CTI Clinical Trial and Consulting Services Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at CTI Clinical Trial and Consulting Services. As an Associate Director, Regulatory Affairs, you will play a critical role in developing and delivering innovative global regulatory strategies for our sonelokimab lead indication(s).Key Responsibilities:Develop and...


  • Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job Overview At MoonLake Immunotherapeutics, we are seeking an experienced Associate Director of Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will play a critical role in developing and delivering innovative global regulatory strategies for our sonelokimab lead indication(s). Responsibilities * Collaborate with...


  • Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time £85,000 - £110,000

    Job Title: Associate Director, Regulatory AffairsJob Type: Permanent, full-timeLocations: Cambridge, UK – Hybrid/RemoteRemuneration: £85,000 - £110,000 + benefitsCpl Life Sciences is seeking an experienced Associate Director, Regulatory Affairs to lead our regulatory strategy for development programs globally. As a key member of our team, you will...


  • Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time £85,000 - £110,000

    Job Title: Associate Director, Regulatory AffairsJob Type: Permanent, full-timeLocations: Cambridge, UK – Hybrid/RemoteRemuneration: £85,000 - £110,000 + benefitsCpl Life Sciences is seeking an experienced Associate Director, Regulatory Affairs to lead our regulatory strategy for development programs globally. As a key member of our team, you will...


  • Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full time

    About the JobWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group in the United Kingdom.Key ResponsibilitiesProvide guidance and support to clients regarding regulatory submissions and activities in the UK.Contribute to the development of PLG's local UK Regulatory Affairs presence, taking responsibility for new...


  • Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full time

    About the JobWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group in the United Kingdom.Key ResponsibilitiesProvide guidance and support to clients regarding regulatory submissions and activities in the UK.Contribute to the development of PLG's local UK Regulatory Affairs presence, taking responsibility for new...


  • Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    About the RoleMoonLake Immunotherapeutics is seeking an experienced Regulatory Affairs professional to join our team as an Associate Director, Regulatory Affairs. This is an exciting opportunity to contribute to the development and delivery of innovative global regulatory strategies for sonelokimab lead indication(s).Key ResponsibilitiesDevelop and implement...


  • Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    About the RoleMoonLake Immunotherapeutics is seeking an experienced Regulatory Affairs professional to join our team as an Associate Director, Regulatory Affairs. This is an exciting opportunity to contribute to the development and delivery of innovative global regulatory strategies for sonelokimab lead indication(s).Key ResponsibilitiesDevelop and implement...


  • Cambridge, United Kingdom Bicycle Therapeutics Full time

    Job DescriptionThe Associate Director, Regulatory Affairs CMC will be responsible for the development, strategy, execution and tracking of CMC regulatory activities for assigned BicycleTx programs or projects.The Associate Director, Regulatory Affairs CMC will be responsible for supporting the delivery of CMC regulatory strategy and submissions for their...


  • Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time

    Job Title: Associate Director, Regulatory AffairsJob Summary:We are seeking an experienced Associate Director, Regulatory Affairs to join our team at Cpl Life Sciences. As a key member of our regulatory affairs team, you will be responsible for leading global regulatory strategies, supporting all areas of development, and collaborating with cross-functional...


  • Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time

    Job Title: Associate Director, Regulatory AffairsJob Summary:We are seeking an experienced Associate Director, Regulatory Affairs to join our team at Cpl Life Sciences. As a key member of our regulatory affairs team, you will be responsible for leading global regulatory strategies, supporting all areas of development, and collaborating with cross-functional...


  • Cambridge, Cambridgeshire, United Kingdom Lifelancer Full time

    Job Title: Associate Director, Regulatory AffairsAs a key member of the MoonLakes team, you will play a crucial role in developing and delivering innovative global regulatory strategies for sonelokimab lead indication(s). Your expertise will be instrumental in ensuring compliance with regulatory requirements and facilitating the approval of all regulatory...


  • Cambridge, Cambridgeshire, United Kingdom Lifelancer Full time

    Job Title: Associate Director, Regulatory AffairsAs a key member of the MoonLakes team, you will play a crucial role in developing and delivering innovative global regulatory strategies for sonelokimab lead indication(s). Your expertise will be instrumental in ensuring compliance with regulatory requirements and facilitating the approval of all regulatory...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job DescriptionThe Associate Director, Regulatory Affairs CMC will be responsible for the development, strategy, execution, and tracking of CMC regulatory activities for assigned BicycleTx programs or projects.This role will support the delivery of CMC regulatory strategy and submissions for their assigned BicycleTx programs or projects, working closely with...


  • Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time

    Job Title: Associate Director, Regulatory AffairsJob Type: Permanent, full-timeLocations: Cambridge, UK – Hybrid/RemoteRemuneration: £85,000 - £110,000 + benefitsCpl Life Sciences is seeking a highly skilled Regulatory Affairs professional to lead strategy for development programs globally, support all areas of development, and support any area of...