Theradex Oncology
Regulatory Affairs Manager/Sr Manager
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Who We Are
Celebrating 40+ Years!
Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials.
Opportunity
Looking to leverage your EU CTR and IRAS expertise in oncology?
We are hiring a Regulatory Affairs Manager/Sr Manager to drive high-impact clinical trial submissions. If you have 5+ years of pharma or CRO experience and deep knowledge of CTIS and IRAS, this role may be for you.
REMOTE: UK or Sweden
Here's how you will make an impact and what you need to succeed:
What You Need to Bring
Education, Experience and Skills Required:
- Bachelor’s degree required, preferably in a life science field or equivalent
- 5+ years in the pharmaceutical industry or a CRO, preferably in a regulatory role
- Deep, working knowledge of EU CTR and UK Regulations.
- Direct experience with CTIS and IRAS CTA preparations and submissions
- Proficiency with Veeva and SharePoint systems
- Direct experience with Development Safety Update Report (DSUR) and Urgent Safety Measures (USM) submissions
- Proficient knowledge of Microsoft Office packages including but not limited to Word and Excel.
- Fluent in English, written and verbal.
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Preferred:
- Experience preparing and reviewing Country-ICFs.
Your Core Responsibilities
Strategic Regulatory Leadership
- Manage and assemble the Master Core Dossier for European CTAs and amendments.
- Provide proactive guidance on regulatory challenges and mitigation strategies.
- Support clients in obtaining Scientific Advice from the EMA and EU Competent Authorities.
- Prepare Orphan Drug Applications and patient-facing documentation.
Cross-Functional Collaboration
- Connect with Clinical Operations, Data Management, Medical Writing, PV, QA, and Drug Distribution.
- Contribute to IMPDs, DSURs, study protocols, and Investigator’s Brochures.
- Support business development initiatives and lead bid defense presentations.
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Compliance & Quality Excellence
- Monitor submissions through eTMF and CTMS tools.
- Lead QC steps for all core dossiers and regulatory documents.
- Assist the Head of Regulatory in writing SOPs, templates, and training the team.
For more information on the responsibilities, skills and competencies needed, click on the link below to view the position and apply.
What we offer:
We offer a friendly and supportive culture that puts people first. We provide a competitive compensation and benefits package including 6% pension contribution, private medical insurance, sick pay and income protection insurance, life assurance and eyecare voucher scheme.
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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