Senior Regulatory Affairs Associate, Clinical

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**Job Description**:
POSITION OVERVIEW:
The Clinical Trial Application (CTA) Regulatory Group consists of regulatory technical experts who are responsible for providing global regulatory operational expertise for CTAs across all regions, excluding US, China and Japan, and act as the primary interface between global Therapeutic Area and Affiliate regulatory colleagues to efficiently and timely deliver high quality and compliant CTA related documents. You will typically take the lead on preparation of regulatory Clinical Trial documentation, including submissions through the EMA Clinical Trial Information System (CTIS); seeking guidance from other colleagues as needed. You will advise Regulatory TA and Affiliate colleagues, plus cross-functional partners and stakeholders on the requirements and pathway needed to obtain, change or maintain CTAs with regulatory authorities. You will typically participate in process updates and/or other special projects related to clinical trials. You will also train and advise new or less experienced Regulatory Affairs colleagues.

EXAMPLE RESPONSIBILITIES:

- Prepare Clinical Trial regulatory submissions, which require interactions with cross-functional in line with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements, regional requirements, and scientific and company policies and procedures.
- Be the operational driver for Clinical Trial Submissions and Notifications in the state-of-the-art Regulatory Document Management System and maintain tracking systems.
- As required, be the critical technical coordinator for Clinical Trial Submissions and Notifications through the EMA Clinical Trial Information System (CTIS), working with a dedicated data entry team to ensure accurate and timely input of data into the EMA CTIS system for Clinical Trial Applications, Modifications and Notifications.
- Be responsible for coordinating, and where possible preparing, Requests for Information from Health Authorities with relevant Global TA Liaisons and cross functional teams.
- Assist with definition, development, and implementation of processes to meet the evolving global CTA needs.
- Participate in and, as needed provide support for the Gilead Regulatory Clinical Trial User Group (CTUG) for sharing of best practice and CTA related discussion
- Raise, inform and resolve any issues that may impact submission process or timelines.
- Review and maintain awareness of regulatory intelligence relating to clinical trials and advise stakeholders accordingly.
- Contributes to process improvements and/or other special projects within Regulatory Affairs related to Clinical Trials.
- Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
- Support inspection readiness activities when applicable.
- Seeks assistance from others as needed.

**REQUIREMENTS**:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience
- Several years' regulatory, quality or compliance experience supporting medicinal products is preferred.
- Experience supporting regulatory submissions for medicinal products is strongly preferred.
- Knowledge and proven execution of CTA Processes in EU, comprehensive understanding of the EU Clinical Trials Regulation, EU Clinical Trials Directive and ICH/GCP is strongly preferred, and knowledge of global requirements advantageous.
- Experience supporting development or changes to clinical trial activities is preferred.
- Experience writing or updating processes is strongly preferred.

Knowledge & Other Requirements
- Demonstrated ability to be a fast learner.
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
- Demonstrates sound knowledge of regulatory requirements and the role of regulatory affairs as these pertain to medicinal products, including knowledge and understanding of ICH standards and varying regional requirements in the assigned markets.
- Knowledge of relevant health authorities, including people, system, processes and requirements.
- Demonstrates strong attention-to-detail and good organizational skills.
- Good project management skills, as evidenced by ability to manage multiple assignments simultaneously without compromise to timelines or quality.
- Ability to quickly learn new software, regulations and processes.
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