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Regulatory Affairs
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IMC Life Sciences Bishop's Stortford, United KingdomMy client are a highly successful Regulatory Affairs Consulting Practice. They serve the Pharmaceutical and Biotechnology industries, from early stage product development through to marketing approval. They have a great culture, excellent values, a very supportive team and signif ...
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Regulatory Affairs Supervisor
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Regulatory Affairs Supervisor
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Regulatory Affairs Supervisor
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Regulatory Affairs Manager
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Manager - Regulatory Affairs - Cambridge, Cambridgeshire, United Kingdom - Bicycle Therapeutics
Description
Job Description Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics.
This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist (Bicycle TICA) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials.Additionally, the company is developing Bicycle Radio Conjugates (BRCTM) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle technology to develop therapies for diseases beyond oncology.
Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA.
We have a new opportunity within our Drug Safety function for a Manager, Drug Safety.This roleprovides clinical safety and pharmacovigilance support to medicines across life-cycle.
Reporting to the Head of Drug Safety, you will oversee the drug safety operation and compliance activities for the development programmes and ensuring inspection readiness.
Serve as the main point of contact for the drug safety operation activities in liaison with external clinical trial vendors and internal cross functional teams.
Responsible for maintaining and oversight of regulatory safety reporting compliance.Effective monitoring and tracking of serious adverse events (SAEs), SUSARs and aggregate reports, including scientific literature.
Oversight & tracking of reconciliation of SAEs between clinical and safety database in close collaboration with data manager and trial CROs, and escalate any issues for prompt resolution.
Laise closely with the Bicycle quality function and act as drug safety point of contact for inspection readiness initiatives, and effective participation in CAPA generation as required.
Provide input and track the generation of project specific plans such as but not limited to Safety Management Plans (SMP) or SAE Reconciliation plans, in close cooperation with project team during set-up and maintenance phaseIn liaison with external vendors, maintain trial master file for safety related documentation in a timely manner
Responsible for departmental initiatives, set up processes & tools for regulatory compliance tracking and effective monitoring. Lead investigation of drug safety process related issues as appropriate.
Support safety surveillance activities, and act as back to team members.
Assists with development and maintenance of Bicycle Drug Safety SOPs.
Monitors assigned project to assure company quality and associated project goals and objectives are being met
Experiencewithinin drug safety and pharmacovigilance including project management in the pharmaceutical industry/CROs
Experience with use of safety databases, preferably Argus but not compulsory
Proficiency in standard desktop software programs (Word, Excel, PowerPoint, Outlook)
State-of-the-art campus environmentwith on campus restaurant and Montessori nursery
~ Flexible working environment
~ Competitive reward including annual company bonus
~ Employee recognition schemes
~28 days annual leave in addition to bank holidays+ option to buy up to 5 additional days annually
~ Employer contribution to pension (employee does not have to contribute)
~ Life assurance cover 4x basic salary
~ Private Medical Insurance, including optical and dental cover.
~ Employee assistance program
~ Health Cash Plan
~ Access to company subsidized gym membership.
~ Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
~ Cycle to work scheme
Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve.
Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.