Associate Director - Regulatory Affairs

Gilead

Cambridge, United Kingdom

We are looking for a driven individual who is passionate about bringing transformational medicines to those in the “International region” with continued unmet medical need.

This is an exciting opportunity for a Regulatory Affairs Associate Director to join the Gilead Global Regulatory Affairs Oncology team to support drug development and registration of oncology assets. This role is focused on Gilead’s Intercontinental and Global Patient Solutions “regions” which includes throughout Asia, Latin America, Africa, Eastern Europe and the Middle East.

In this leadership role you will provide strategic and technical advice from development throughout the whole product lifecycle for the growing Gilead Oncology projects/product portfolio.

Core activities are to plan, prepare and progress new product registrations, and subsequent post-approval safety and indication updates. In the role you will be expected to work cross-functionally with a diverse number of stakeholders both internally and externally to Gilead.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Responsible for formulating and leading regulatory strategies for designated products in the International region. This ranges from new product licenses to lifecycle activities and have oversight of all regulatory aspects of the application;
Partner within Global Regulatory affairs (including Global Regulatory Leads), the Development and Commercial organization. To lead collaborations with cross functional partners to ensure optimal development execution of the agreed regulatory strategy;
Responsible for overseeing the preparation of regulatory submissions products in the therapeutic area and execution of agreed strategies within the region;
To lead and establish strong relationships with Gilead affiliates and distributor partners (when required) and serve as point person for knowledge for their product to these key stakeholders;
Deep and expert understanding of the regulatory environment leveraging internal knowledge and external regulatory intelligence;
Responsible for overseeing and leading the preparation and maintenance of labelling to support MAAs and other post-licensing activities. Ensures that any updates to the Product Company Core Data Sheet (CCDS) are implemented in a timely manner;
Ensures that updates to the product packaging components are implemented in line with approved labelling in line with approved labelling and agreed timelines;
Participates and leads regulatory team meetings and recognized as a knowledgeable resource for Regulatory Affairs in other departments;
Participates and leads collaborative efforts across function in process improvements initiatives;
Able to use internal electronic systems for planning, preparing, tracking and storing submissions to regulatory agencies;
Contributes to the culture of continuous improvement across regulatory affairs helping team members learn and develop aspects of regulatory strategy and research, to lead or contribute to regional strategies.

CORE COMPETENCIES

Direct experience in regulatory affairs in pharmaceutical industry across International markets, in regulatory submissions and good understanding of the drug development process from development through to post-marketing;
In depth knowledge of regulatory requirements, including ICH requirements and regional requirements. Has appreciation of current global and regional trends in Regulatory Affairs;
Knowledge of current global and regional trends in biopharmaceutical regulatory affairs with proven effectiveness applying this knowledge to optimize team deliverables and results within the International Region;
Previous experience of working with Emerging markets, biological products and/or in the oncology therapeutic area would be an advantage but not essential. Excellent organizational skills and ability to work on several projects with tight timelines;
Clear ability to lead cross-functional teams, and develop, communicate and implement regulatory strategy;
Excellent verbal and written English communication skills, and demonstration of excellent interpersonal skills;
Excellent planning and organisational skills with the ability to work simultaneously on multiple projects with tight timelines;
Demonstrated effectiveness in cooperation and teamwork, with analytical and assessment skills.

EDUCATION and/or EXPERIENCE REQUIRED

Life science degree and demonstrated broad and/or depth of experience in pharmaceutical regulatory affairs across at least the International region, including leadership of major applications and support of associated health authority interactions.

The Gilead Difference

Everyone at Gilead is motivated by our overarching mission to discover and deliver innovative therapies that improve patient care in areas of unmet medical needs. But it’s just what we do that gives us an edge, it’s how we do it. We expect everyone at Gilead to lead by example, guided by our core values: