Senior Regulatory Affairs Manager

Celebrating 40+ Years! Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. 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. 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.

We are hiring a full time (Homebased/Remote) Senior Regulatory Affairs Manager either based in the UK, France, Italy, Spain, Sweden or Republic of Ireland. The primary responsibilities of this position include, but are not limited to, the following:

• Provides regulatory (strategic, tactical, operational) input to all projects managed by Regulatory Affairs Europe, as needed.
• Manages preparation, assembly and submissions in EU/EEA and UK of Clinical Trial Applications (CTAs), amendments/modifications and notifications.
• Country-level Informed Consent Forms and other patient facing documentation.
• Other regulatory documents required for submission purpose only e.g., GDPR statement, Recruitment Procedure.
• Participates in the quality control (QC) steps involved for all the above.
• Tracks, reports and files CTA and amendment/modification submissions/approvals in local regulatory repository, electronic Trial Master Files (eTMF) and other applicable systems.
• Prepares presentations for Kick Off Meetings (KOM) with clients and represent Regulatory Affairs at such meetings.
• Identifies and proactively communicates regulatory issues and risks including risks related to country specific requirements and provides associated mitigation as required to ensure applications and notifications are submitted within agreed timelines.
• Identifies country specific requirements as well as the need for additional country specific applications besides CTIS/IRAS applications e.g., related to radiation safety and biobanks.
• Serves as key regulatory liaison for multi-continental projects on behalf of Theradex Oncology (Europe).
• Liaison with other departments within Theradex, including but not limited to Clinical Operations, Medical Writing, Pharmacovigilance, Quality Assurance and Drug Distribution.
• Act as Subject Matter Expert for specific assigned topics e.g., Medical Device, National requirements related to C-ICF in a group of countries.
• Responsible for assigned Regulatory SOPs and other Quality Documents and ensure they are updated/reviewed within set timelines.
• Proactively identify the need for ad-hoc updates of Regulatory Quality Documents.
• Review scientific documents such as IMPDs, DSURs, study protocols and IBs and provide input from a regulatory perspective when requested.
• Validate and provide input into our clients’ regulatory development strategies, support our clients in preparing for Scientific Advice meetings with EU Competent Authorities and the EMA and prepare applications such as Orphan Drug, Compassionate Use where required.
• Keep up to date and interpret guidelines and regulations for preparation of CTAs and in response to sponsor questions.
• Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by ECs and CAs.
• Supports the Head of Regulatory Affairs in business development activities including the preparation of client proposals and bid defense meetings.
• Provides regulatory training to other members of the team as required.

What You Need

• Level of Education: Bachelor’s degree required preferably in a life science field or equivalent.
• Prior Experience: At least 5 years of experience from the pharmaceutical industry or CRO in a regulatory role within the area clinical trials required.
• Prior experience in a CRO environment preferred.
• Direct experience of CTIS and IRAS CTA preparations and submissions is required.
• Experience from national applications such as GMO, radiation safety is preferred.

Skills and Competencies

• Completion of Theradex Oncology training programme.
• Detailed knowledge of ICH-GCP and EU and UK 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 management skills and the proven ability to meet deadlines.
• Ability to anticipate problems relating to projects and to develop and implement solutions.
• Fluent knowledge of written and verbal English.
• 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.