AdvertisementSenior/ Regulatory Specialist
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.
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The Regulatory Specialist II 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 II 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. May take the role of Regulatory Lead on assigned projects (single country or small size studies), with close supervision of the Functional Area Lead.
- Proposes regulatory strategy and timelines for initial clinical study application and amendment submissions to Competent Authority and Ethics Committee(s) in the assigned countries and/or projects with supervision of more senior regulatory staff;
- In the role of the Regulatory Lead, provides leadership in assigned projects in terms of regulatory submissions in line with established strategies and timelines;
- 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;
- In the role of Regulatory Lead in assigned projects, prepares regulatory submission packages for initial clinical study applications and amendments to Competent Authorities and Ethics Committees acording to national, EU and international requirements, guidelines and laws;
- Ensures that regulatory deliverables for the assigned country/ies and/or projects are on time and with quality;
- Reviews 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;
- In the role of Regulatory Lead in assigned projects, reviews clinical study application and amendment submission packages before submission to Competent Authority and Ethics Committee for completeness, accuracy and ensures that corrections are implemented appropriately;
- In the role of Regulatory Lead in assigned projects, acts as the main point of contact for clients for all aspects related to clinical study registration to Competent Authorities and Ethics Committees throughout the study lifecycle;
- Proactively communicates with assigned team members across relevant functions in order to drive project success;
- Identifies project and/or country specific problems and risks related to clinical study applications and amendments to Competent Authorities and Ethics Committees and works with internal and external team members to provide and implement solutions, with close supervision of the Functional Area Lead;
- Supports development of country regulatory intelligence data related to clinical study application and amendment submissions to Competent Authorities and Ethics Committees;
- Maintains in-depth knowledge on regulatory requirements for assigned country/ies and EU requirements, laws and regulations related to clinical study applications and amendments to Competent Authorities and Ethics Committees by regularly monitoring relevant resources and websites. Communicates relevant updates to FAL and internal team members;
- Keeps regulatory department trackers up to date;
- Keeps the relevant project level reporting tool up to date as per SOP, relevant TMF plan, Sponsor requirements and shares relevant information with other parties as needed;
- May participate in Kick-off meetings, audits and other project related meetings according to company / client needs;
- Participates in internal and external teleconferences/meetings;
- Provides mentoring to more junior staff;
- Complies with training expectations relevant for Regulatory Specialist II;
- Additional tasks such as Pharmacovigilance related submissions to Competent Authorities and/or Ethics Committees may be assigned as per business needs;
- Performs other duties as assigned by the Functional Area Lead.
- Minimum of Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree preferred;
- Minimum of 2 years of experience in Regulatory Affairs work or related work in a Clinical Research environment;
- Very good knowledge of ICH/GCP guidelines, local regulatory requirements, European regulations and Standard Operating Procedures;
- Very good understanding of clinical trial registration process in the assigned country/ies;
- Advanced planning, organization and problem-solving abilities;
- Ability to work in a dynamic fast-paced, high volume environment and meet deadlines;
- Advanced organizational and time management skills in order to balance working on multiple projects in parallel;
- Advanced verbal and written communication and interpersonal skills;
- Advanced analytical and negotiation 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.
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.