Theradex Oncology
Regulatory Affairs Manager/Senior Manager
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Who We Are
Celebrating 40+ Years!
Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.
What You'll Do
We are hiring a full time (Remote) Regulatory Affairs Manager/Senior Manager either based in the UK or Sweden
The primary responsibilities of this position include, but are not limited to, the following:
- Provides strategic regulatory input to all assigned projects.
- Management, preparation, assembly of the Master Core Dossier and submissions of European:
- Clinical Trial Applications (CTA) and amendments
- Country-level Informed Consent and other patient facing documentation
- Tracks, reports and files CTA and amendment submissions/approval progress in electronic trial master files (eTMF) clinical trials management system (CTMS) or other applicable systems.
- Proactively provides strategic direction to the client on regulatory specific issues and provides associated mitigation as required.
- Participates in the quality control (QC) steps involved for all the above.
- Serves as key regulatory liaison for multi-continental project on behalf of Theradex (Oncology (Europe). Liaison with other departments within Theradex, including Clinical Operations, Data Management, Medical Writing, Pharmacovigilance, Quality Assurance and Drug Distribution.
- Strategic cross-functional interaction with a variety of departments to provide EU regulatory solutions to problems including the management of timelines to complete regulatory submissions on time
- Responsible for providing assistance to effectively perform the planning, critical reviews and scientific writing of a number of regulatory activities such as IMPDs, DSURs, study protocols, IBs and patient information sheets in order to successfully obtain the regulatory approval
- Validate and provide input into our clients’ regulatory development strategies, support our clients in preparing for and obtaining Scientific Advice from EU Competent Authorities and the EMA and prepare Orphan Drug Applications where required
- Supports clients in preparing for advice meetings with national RAs or the European Medicines Agency.
- Maintains an awareness of cancer therapy and clinical trial design and conduct
- Maintains in depth knowledge of Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials in Europe.
- Supports Head of Regulatory in business development activities including the preparation of client proposals and bid defense meetings.
- Supports Head of Regulatory in the preparation of quality documents such as SOPs and templates
- Provides regulatory training to other members of the team as required.
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Level of Education
- Bachelor’s degree required preferably in a life science field or equivalent
Prior Experience
- Substantial EU regulatory experience with 5+ years experience in the pharmaceutical industry, preferably in a regulatory role
- Pharmaceutical company or CRO
- Direct experience of CTIS and IRAS CTA preparations and submissions is required
- Experience with Development Safety Update Report (DSUR) and Urgent Safety Measures (USM) submissions required.
- Preparing and Reviewing Country-ICFs- Preferred
- Veeva and Sharepoint systems is required
- EU CTR and UK Regulation knowledge is required
Skills and Competencies
- Detailed knowledge of ICH-GCP and local regulatory agency and ethics committee regulations and requirements.
- The ability to stay informed about new guidelines and regulations as they are issued by regulatory authorities.
- Demonstrates ability to build and maintain effective relationships with others, establishing collaborative partnerships, trust and shared purpose
- Excellent interpersonal skills/strong leadership abilities
- Strong management skills and the proven ability to meet deadlines
- Ability to anticipate problems relating to projects and to develop and implement solutions.
- Fluent in English, written and verbal.
- Highly organized and result-oriented.
- Ability to work independently as well as in a team environment.
- Proficient knowledge of Microsoft Office packages including but not limited to Word and Excel.
This job does not offer company sponsorship
Theradex is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment.
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