Clinical Trial Regulatory Lead
- Experience Level
- Experienced (non-manager)
Clinical Trial Regulatory Lead
Roche is an innovative, curious and diverse company with over 90'000 professionals in 150 countries. As a global leader in research-focused healthcare, Roche is committed to optimising the way we work by learning and growing and are seeking people who share the same ambitious vision.
We support our staff in the development of their knowledge and skills. Further local and global career opportunities are offered to people who demonstrate talent and aptitude.
We currently have an exciting opportunity for a Clinical Trial Regulatory Lead to join our dynamic Global Product Development Regulatory team (PDR) in Welwyn. We are looking for someone keen to strengthen their clinical trial regulatory knowledge to enable the future of clinical trials by pushing boundaries to get patients faster access to treatments and become an integral team member on several programmes dedicated to changing patient's lives.
The Impact of the role
- Enable the registration and launch of new products
- First point of contact for regulatory clinical trial activities
- A Strategic partner, challenging strategies, connecting the dots and taking smart risks
- Experts in regulatory clinical trials, providing guidance to our stakeholders
- Embrace changes translating this for our stakeholders
- Efficiently enable the business to accelerate delivery of clinical trial activities
In this role you:
- Provide expert advice to EU and International Regulatory Managers on external and internal requirements for CTAs and monitor the regulatory landscape for changes.
- Represent the Clinical Trial activity on regulatory and study management teams.
- Cross functional (including CROs) coordination and collaboration to plan, compile, dispatch and track submissions and approvals of core CTAs or common documents and amendments, using the appropriate systems.
- Participate in projects and initiatives outside of the core scope of Clinical Trial Regulatory Management responsibilities.
Who are you?
- We are looking for an experienced and committed regulatory professional bringing:
- Strategic, Innovative and Creative Thinking: You apply regulatory and scientific knowledge to determine solutions and solve complex problems. You demonstrate the ability to assess priorities and set strategies to align with/ meet business needs. You seek improvements (including digital solution) in work processes while using judgment to balance creativity with compliance and the requirement to meet timelines.
- Communication and Negotiation Skills: You can influence individuals or groups on more than one level who may have different interests or goals to reach consensus and achieve team objectives. You are able to communicate effectively in a multicultural, multi-functional environment.
- Teamwork: You work effectively to share responsibility as a team member in a customer focused environment
- Technical Competence: Good knowledge of EU Clinical Trial Directive, Regulation and respective guidance documents; excellent working knowledge of SOPs dealing with EU clinical trial requirements. Knowledge of the regulatory requirements of key International countries (as well as other countries) in order to support global trials. Good knowledge of GCP principles applied globally
Minimum Qualifications and Experience
- Demonstrated practical working experience the regulatory management of clinical trials.
- BS/BA degree, or good relevant experience in pharmaceutical industry
Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.
This role is open in Welwyn, UK.