Regulatory Affairs Manager/Sr Manager (6 Month Contract)
vmysmartpros · Anywhere
FULL-TIME
Remote
Posted Sep 18, 2026
Job Description
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
Contract Regulatory Affairs Manager/Senior Manager
Remote either based in the UK or Sweden
Opportunity:
Contract | 6-Month T&M | Expert in EU Clinical Trial Regulations & CTA Submissions
The primary responsibilities of this position include, but are not limited to, the following:
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.
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
What You Need
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- PreferredVeeva and Sharepoint systems is requiredEU 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.
Apply To this Job
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
Contract Regulatory Affairs Manager/Senior Manager
Remote either based in the UK or Sweden
Opportunity:
Contract | 6-Month T&M | Expert in EU Clinical Trial Regulations & CTA Submissions
The primary responsibilities of this position include, but are not limited to, the following:
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.
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
What You Need
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- PreferredVeeva and Sharepoint systems is requiredEU 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.
Apply To this Job
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