AdvertisementRegulatory Specialist | Ukraine
KCR is a clinical development solutions provider for the biotechnology and pharmaceutical industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR now operates across five regions: North America, Western Europe, Central Europe, Eastern Europe, and Australia, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.com.
We see the human behind every number.
KCR is a clinical development solutions provider for the biotechnology, pharmaceutical, and medical device industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.com. We see human behind every number.
The Regulatory Specialist I participates in realization of all aspects of clinical study registration to Competent Authorities and Ethics Committees in assigned country/ies according to Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), International Conference on Harmonization (ICH) guidelines and local laws and regulations. The Regulatory Specialist I is responsible for timely delivery of submissions to Competent Authorities and Ethics Committees in the assigned country/ies throughout the study lifecycle and ensures KCR's and client's quality expectations are met.
The duties associated with the role include:
- Proposes regulatory strategy and timelines for initial clinical study application and amendment submissions to Competent Authority and Ethics Committee(s) in the assigned country/ies with close supervision of more senior regulatory staff/Regulatory Lead;
- Prepares country specific regulatory documents and adapts regulatory submission packages for initial clinical study applications and amendments to local Competent Authority and Ethics Committee(s) according to local requirements, guidelines and laws in the assigned country/ies;
- Ensures that regulatory deliverables for the assigned country/ies are on time and with quality;
- Assists in reviewing local clinical study application and amendment submission packages of assigned country/ies before submission to Competent Authority and Ethics Committee for completeness, accuracy and ensures that corrections are implemented appropriately;
- Supports development of country regulatory intelligence data related to clinical study application and amendment submissions to Competent Authorities and Ethics Committees;
- Keeps regulatory department trackers up to date;
- Keeps the relevant project level reporting tool and filing up to date as per SOP, relevant TMF plan, Sponsor requirements and shares relevant information with other parties as needed;
- Participates in internal and external teleconferences/meetings;
- Additional tasks such as Pharmacovigilance related submissions to Competent Authorities and/o Ethics Committees may be assigned as per business needs.
- Minimum of Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree preferred;
- Minimum of 1 year of clinical research experience;
- Good knowledge of ICH/GCP guidelines, local regulatory requirements, European regulations and
- Standard Operating Procedures;
- Good understanding of clinical trial registration process in the assigned country/ies;
- Good planning, organization and problem-solving abilities;
- Ability to work in a dynamic fast-paced, high volume environment and meet deadlines;
- Good organizational and time management skills;
- Computer competency;
- Fluent in local office language and in English, both written and verbal;
- Ability to travel occasionally, including overnight stays as necessary, consistent with project needs and office location.
At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits that comply with national regulations and provide the coverage that best meets employee needs.
To show that you are appreciated in our team, while working at KCR you will be provided with:
Ability to join fast-growing international CRO company and develop knowledge of clinical trials industry;
Possibility of getting involved in multinational studies;
Onboarding process to enable you fast takeover of duties;
Peer Buddy Mentor who will introduce you to the organization;
Open culture based on our values: learning, customer focus, accountability, commitment, tenacity and determination to succeed;
Empowering workspace, offering opportunities to share ideas and influence company services development worldwide;
Mentoring and training programs related with clinical trials, therapeutic areas, soft skills development;
Additional days-off for certain occasions.