Associate Director, Regulatory Affairs, Oncology

Gilead Sciences; Greater London; On-site; GBP 150,000 - 200,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Regional Regulatory Lead to oversee complex products and define regulatory strategies. The position involves managing multiple regulatory projects, overseeing submissions, and representing the company in negotiations with regulatory authorities. A BA/BSc or advanced degree in life sciences and significant regulatory experience in the biopharma industry are required. Strong communication and negotiation skills are essential for success in this role.

Qualifications

• Significant regulatory experience in the biopharma industry, regulatory agency, or clinical research.
• In-depth understanding of FDA and EMA regulatory requirements.
• Experience leading regulatory activities for biopharmaceutical products.

Responsibilities

• Act as Regional Regulatory Lead for complex products in assigned therapeutic area.
• Define regulatory strategies and manage multiple regulatory projects.
• Oversee preparation and maintenance of regulatory submissions.

Skills

Proofreading

FDA Regulations

Clinical Trials

Research & Development

Strong communication skills

Strong negotiation and conflict resolution skills

Education

BA / BSC or advanced degree in life sciences

Tools

Adobe Acrobat

Job description

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.

Job Description

Position Overview

You will act as the Regional Regulatory Lead on more complex or multiple products compounds indications or projects in the assigned therapeutic (TA) area. You will typically be assigned multiple products or projects to lead manage and oversee simultaneously. You will define the regulatory strategy plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams. You will typically serve as a Gilead contact to / for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions regulatory labelling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will also play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities.

Responsibilities

• As needed represents Gilead in negotiations with regulatory authorities.
• Makes significant contributions to the ongoing development and refinement of regulatory strategies processes standards practices efficiencies and capabilities.
• Represents Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional / cross-regional Regulatory Submission Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.
• May participate on other Sub-teams (e.g. Study Management Clinical Nonclinical Biomarkers) or assign such to other colleagues and oversee and guide their sub-team participation.
• Defines the regulatory strategy for multiple Gilead products or projects.
• Proactively identifies regulatory or related risks / issues and develops mitigation and / or contingency plan.
• Oversees and guides the preparation compilation and timely filing of regulatory submissions which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests briefing packages original Investigational New Drug (IND) IND amendment and routine submissions (e.g. Development Safety Update Reports / DSURs Investigator Brochure / IB updates etc.).
• Oversees and approves the authoring of regulatory documents including meeting requests Module 1 documents for original IND etc.
• Oversees and guides labeling packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.
• Critically reviews documents for submission to regulatory authorities.
• Provides matrix management and leadership to project teams.
• Provides accurate and thorough input and recommendations into resource plans required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation including budgets.
• Ensures own work complies with established practices policies and processes and any regulatory or other requirements.

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.

Rest of World Education & Experience

BA / BSC or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry regulatory agency clinical research or other related healthcare environment. Experience leading a broad range of regulatory activities and setting the regulatory strategy for biopharmaceutical products.

Knowledge & Other Requirements

• In-depth understanding of U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH) standards for medicinal products. Understands varying regional or country regulatory requirements for assigned markets.
• In-depth knowledge of current global and regional trends in biopharmaceutical regulatory affairs. Proven effectiveness applying this knowledge to optimize team deliverables and results.
• Demonstrates advanced regulatory and business knowledge and advanced analytical abilities as evidenced by strengths in assessing complex multidisciplinary data understanding and effectively advising on its regulatory implications.
• In-depth knowledge of relevant health authorities (HAs) including people system processes and requirements as evidenced by past effectiveness and successes in conducting HA interactions.
• Able to represent Gilead to regulatory authorities when managing standard and non-standard negotiations.
• Thorough knowledge of the drug development process including all key functions involved in the various stages of drug development from early research through post-marketing.
• Strong leadership presence with demonstrated ability to lead without authority and influence programs projects and / or initiatives.
• Strong interpersonal skills and understanding of team dynamics.
• Strong communication and organizational skills.
• Strong negotiation and conflict resolution skills.
• When needed ability to travel.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors

Please apply via the Internal Career Opportunities portal in Workday.

Required Experience

Director

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type

Full-Time

Experience

years

Vacancy

1