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I'm an HR professional with strong organizational & customer support skills. I have the expertise in arranging client meetings, telephone/ F2F…

ABOUT THIS ROLE

Theradex Oncology is celebrating 40+ Years. It is a full-service CRO conducting cancer clinical trials in U.S., Europe and Asia. We are looking for Senior Regulatory Affairs Manager to join our team.

You will work collaboratively with cross-departmental activities on all regulatory activities to drive best practice across the organisation and provide strategic, tactical and operational input to all projects as needed.

The role can be based remotely in the UK, France, Italy, Spain, Sweden or Republic of Ireland.

KEY ACCOUNTABILITIES

• Manage preparation, assembly and submissions of CTAs. Country ICFs in EU/EEA and UK
• Prepares presentations and represent the department at Kick Off Meetings (KOM) with clients.
• Identify country specific requirements and 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.
• Be Subject Matter Expert for specific assigned topics e.g., Medical Device, National requirements related to C-ICF in a group of countries
• Review of Regulatory SOPs and other Regulatory Quality Documents.
• Review and provide input from a regulatory perspective on scientific documents (IMPDs, DSURs, study protocols and IBs).
• Validate and provide input into clients’ regulatory development strategies, support 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.
• Support Head of Regulatory Affairs in business development activities such as preparation of client proposals and bid defense meetings.
• Provide regulatory training as required.

REQUIREMENTS FOR THIS POSITION

• Bachelor’s degree in a life science field or equivalent required.
• Minimum of 5 years of experience in the pharmaceutical industry or CRO in a regulatory role within the area clinical trials
• Direct experience of CTIS and IRAS CTA preparations and submissions is required
• Experience from national applications such as GMO, radiation safety is preferred
• Fluent knowledge of written and verbal English
• 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.
• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research and Other

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