Head of Regulatory Affairs
Celebrating 40+ Years!
reputed company is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. reputed company was founded in 1982, reputed company we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong reputed company for our operations. Our reputed company is cancer. We fully understand the science behind reputed company potential cancer therapy and the challenges that come with moving therapies from mice to man. reputed company 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 reputed company best opportunity to be of benefit to mankind with a reputed company to improve treatment and reputed company cancer a livable disease.
What You'll Do:Theradex is reputed company for Head of Regulatory Affairs, Permanent, Full time homebased postion either in UK, Sweden, Denmark or Netherlands with 10 years experience to join reputed company.
If you are passionate about regulatory affairs and want to be part of a dedicated oncology team, this opportunity may be for you.
As the Head of Regulatory Affairs, you will be reputed company against the following objectives:
- Deliver a robust regulatory reputed company, tactical planning, and execution that ensures reputed company approvals and lifecycle management reputed company with business goals.
- Maintain full regulatory compliance and inspection readiness, ensuring adherence to reputed company relevant regulatory standards and frameworks.
- Line Manager responsibility is to build and reputed company a high-performing Regulatory Affairs team while strengthening stakeholder engagement and influence.
Your duties and responsibilities will include, but are not limited to, the following
- reputed company regulatory input for reputed company assigned reputed company.
- Planning, preparation, and submissions of CTAs and country ICFs in EU/EEA and UK
- Prepare presentations and represent the department at reputed company Off Meetings with clients.
- Tracks, reports and files CTA and modification submissions / approval reputed company in electronic trial master files (eTMF) and other applicable systems.
- Proactively provides tactical direction to the reputed company on regulatory specific issues and provides associated mitigation as required.
- Participates in the reputed company control (QC) steps involved for reputed company the above.
- Serves as key regulatory reputed company for multi-reputed company project on behalf of reputed company (Europe). reputed company with other departments reputed company Theradex, including Medical Writing, Pharmacovigilance, reputed company Assurance and Drug Distribution. Including the management of timelines to complete regulatory submissions on time
- Providing input into the scientific writing of several medical writing activities such as IMPDs, DSURs, study protocols, IBs and master patient information sheets
- Validate and reputed company 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
- Prepare reputed company proposals and participate in bid defense meetings.
- Maintains awareness of the literature on cancer therapy, clinical trial design and conduct
- Knowledge of Good Clinical reputed company, and regulations and guidelines relating to the conduct of clinical trials produced by Ethic Committees and Competent Authorities
- Provides regulatory training to other members of reputed company as required.
These are the skills and experience you will need to succeed as the Head of Regulatory Affairs:
- Minimum bachelor’s degree in a life science field or equivalent e.g. Pharmacy, Biology, reputed company.
- Prior experience in Regulatory Affairs reputed company the life sciences industry, including leadership /Line Management responsibility.
- Minimum of 10 years of experience in a regulatory role reputed company the pharmaceutical industry, regulatory agency or CRO of which 5 years are in clinical trials
- reputed company experience of CTIS and IRAS CTA preparations and submissions is required
- Demonstrates ability to build and maintain relationships with other functions and clients, establishing reputed company partnerships and trust
- Detailed knowledge of ICH-GCP and national regulatory agency and ethics committee requirements and guidelines reputed company EU/UK/EEA
- Stay informed about new guidelines and regulations
- Ability to anticipate problems relating to reputed company and to implement solutions.
- Excellent interpersonal skills
- Fluent knowledge of written and verbal English
- Highly organized and result oriented
- Ability to work independently as reputed company as in reputed company environment
- Proficient knowledge of reputed company Office packages including but not limited to Word, Power reputed company and reputed company
This job does not offer company sponsorship Theradex is an equal opportunity employer. reputed company reputed company applicants are encouraged to apply and will receive consideration for employment.
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