Regulatory Affairs Associate
6 months ago
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 others when required.
- Partake in the process improvements and/or any other special projects in regulatory affairs linked to clinical trials.
- Assist with expediting and improving regulatory CTA administrative actions by mentoring and advising new or less experiences personnel.
- Help with inspection promptness actions when suitable.
- Guarantee that own work complies with formed practices, policies and procedures, as well as any regulatory or any other necessities.
- Other duties may be assigned to this role.
**Key Skills and Requirements**:
- Familiarity working in an administrative role within a corporate or linked business work setting, preferably within a healthcare sector or educated with a degree level in a scientific field is desirable.
- Acquaintance with regulatory CTA connected work experience assisting medicinal products.
- Previous involvement authoring or updating procedures would be ideal.
- Able to learn quickly as well as be flexible and adaptable to change, move between projects easily as well as offer aid/knowledge where required.
- Know-how of regulatory CTA needs and the role of regulatory affairs as these pertain to medicinal product clinical trials, which involves comprehension of ICH standards and contrasting regional needs in the allocated markets.
- An organised individual with a high attention to detail.
- Computer literacy.
- Project management abilities with the capacity to handle various tasks concurrently without compromise to timelines or quality of work.
- Communication skills both verbally and in writing as well as clear and concise.
- Works well in a team within a highly matrixed 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.
LI-DB5
Regulatory
-
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeGilead Sciences, Inc. is seeking a highly motivated and experienced Senior Associate, Regulatory Affairs CMC to join our team.Job Requirements:Minimum 3 years of experience in Regulatory Affairs CMC or relevant pharmaceutical industry experience.Knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional...
-
Regulatory Affairs Associate Ii
8 months ago
Cambridge, United Kingdom Proclinical Full timeProclinical 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. -...
-
Cambridge, Cambridgeshire, United Kingdom Sobi group Full timeJoin Sobi's Team: We are seeking an experienced Associate Medical Director, Regulatory Affairs to join our team of experts in clinical development and regulatory affairs.About the Role: The successful candidate will be responsible for leading clinical development activities, providing scientific and medical input to clinical study documents, and...
-
Associate Director, Regulatory Affairs
2 weeks ago
Cambridge, United Kingdom MoonLake Immunotherapeutics Full timeJob PurposeAs 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...
-
Associate Director, Regulatory Affairs
3 months ago
Cambridge, United Kingdom MoonLake Immunotherapeutics Full timeJob PurposeAs 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...
-
Regulatory Affairs Specialists
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Vertex Ventures HC Full timeJob Title: Compliance OfficersEstimated Salary: $85,000 - $110,000 per year.Bicycle Therapeutics is a pioneering pharmaceutical company dedicated to developing innovative treatments for complex diseases. As a Senior Associate in Regulatory Affairs, you will play a critical role in shaping the company's regulatory strategy, ensuring compliance with global...
-
Associate Director, Regulatory Affairs CMC
2 weeks ago
Cambridge, United Kingdom Bicycle Therapeutics Full timeThis job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board.Company DescriptionBicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short...
-
Regulatory Affairs Director
1 week ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full timeOverviewCpl Life Sciences is seeking a Senior Director Regulatory Affairs to join our team. This role offers the opportunity to lead client projects, provide strategic regulatory advice, and ensure compliance with UK, EU, and US health authorities.About the RoleAs Senior Director Regulatory Affairs, you will be responsible for preparing regulatory submission...
-
Associate Director, Regulatory Affairs
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeJob Purpose 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...
-
Regulatory Affairs Director
2 months ago
Cambridge, Cambridgeshire, United Kingdom Lifelancer Full timeJob DescriptionCompany Overview: Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT.We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains. Our mission is to provide innovative solutions for businesses and professionals in the industry.SalaryThe estimated salary for this position...
-
Regulatory Affairs Director
1 week ago
Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full timeJob Title: Regulatory Affairs DirectorWe are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at Bicycle Therapeutics. The successful candidate will be responsible for developing and executing global regulatory CMC strategy and submissions for assigned programs or projects.The ideal candidate will have extensive...
-
Regulatory Affairs Expert
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Thor Companies Full timeRegulatory Affairs Expert WantedWe are seeking a Regulatory Affairs Expert to join our team in Cambridge, UK. The successful candidate will have a strong background in pharma/biopharma and be able to work independently.About the Role:The ideal candidate will have at least 10 years' experience in regulatory affairs.Proven ability to manage projects and...
-
Regulatory Affairs Specialist
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Voisin Consulting SARL Full timeAbout VCLSWe are a leading consulting firm offering expert regulatory services to the pharmaceutical and medical device sectors. Our team is dedicated to providing high-quality support to our clients, ensuring compliance with regulatory requirements.This 30-month programme is designed for recent graduates with an interest in medicines and a desire to build a...
-
Regulatory Affairs Expert
7 days ago
Cambridge, Cambridgeshire, United Kingdom VCLS Full timeWe are seeking a highly experienced Regulatory Affairs Expert to join our growing team at VCLS. This role is ideal for someone with 4+ years of experience in regulatory affairs and a strong background in Clinical Trial Submissions.The successful candidate will play a key role in driving forward regulatory processes, ensuring compliance, and contributing to...
-
Regulatory Affairs Specialist
6 days ago
Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full timeCompany OverviewBicycle Therapeutics is a pioneering pharmaceutical company pushing the boundaries of innovation in drug development. Our mission is to create life-changing therapies for underserved diseases.About the RoleWe are seeking a skilled Senior Associate, Regulatory Affairs to join our team. As a key member of our regulatory department, you will be...
-
Associate Director, Regulatory Affairs CMC
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full timeThis job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board. Company Description Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic...
-
Regulatory Affairs Specialist
1 month ago
Cambridge, Cambridgeshire, United Kingdom Vectura Group Full timeJob SummaryWe are seeking a skilled Regulatory Affairs Specialist to join our team at Vectura Group. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with global regulations and guidelines for medical devices and drug-device combination products.Key Responsibilities:Lead regulatory activities across...
-
Regulatory Affairs Specialist
1 month ago
Cambridge, Cambridgeshire, United Kingdom VCLS Full timeVCLS is seeking a highly skilled Regulatory Affairs Specialist to drive forward regulatory processes, ensure compliance, and contribute to innovative clinical trials. The ideal candidate will have 4+ years of experience in Regulatory Affairs, with a focus on Clinical Trial Submissions (CTS). They will possess a deep understanding of regional and local...
-
Regulatory Affairs Specialist
4 days ago
Cambridge, Cambridgeshire, United Kingdom Dr. Reddy's Laboratories Full timeJob Title: Regulatory Affairs SpecialistEstimated Salary: $80,000 - $110,000 per annumAbout UsWe are a leading multinational pharmaceutical company based across global locations. Our mission is to accelerate access to affordable and innovative medicines.Job DescriptionThe successful candidate will be responsible for preparation and submission of UK MAA...
-
Regulatory Affairs Expert
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full timeJob OverviewWe are seeking a highly experienced Senior Director to lead our Regulatory Affairs team at Cpl Life Sciences. This role will provide strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input.Key Responsibilities:Lead client projects, providing expert regulatory guidance...