Director, Regulatory Affairs - Inflammation

Description

As a Global Regulatory Lead, you will be accountable for the development and execution of global regulatory strategies for early and late-stage assets targeting fibrotic diseases within the Inflammation TA.

You will work closely with the Inflammation Fibrosis Regulatory Affairs (RA) Franchise Lead, Regional Regulatory Liaisons and cross-functional stakeholders to communicate a clear vision and provide strategic, actionable regulatory guidance that successfully enables regulatory approvals across target regions, in compliance with appropriate regulations.

You will provide operational and technical regulatory assistance through all stages of clinical development and oversee preparation and maintenance of global regulatory submissions - guiding and advising Regional Regulatory Liaisons and other colleagues as needed.

You will also lead Regulatory Project Teams and represent Inflammation RA as a subject matter expert on cross-functional core and sub-teams.

You will play a leadership role in ad-hoc or special projects that continuously improve or otherwise advance RA capabilities, and help develop the Inflammation TA's Regulatory leadership pipeline through coaching and mentoring other Regulatory colleagues.

EXAMPLE RESPONSIBILITIES :

Accountable for the development and implementation of high quality, globally aligned regulatory strategies to support Gilead Inflammation assets targeting fibrotic diseases from early development through registration and lead Gilead in key interactions with Health Authorities.

Oversee and guide the preparation, compilation, and timely filing of regulatory submissions via cross-functional interactions for commercial or investigational product(s).

Examples include New Drug Applications (NDA / MAAs), Health Authority Interaction documents (eg : meeting requests, briefing packages), original Investigational New Drug (IND) applications, and routine submissions (e.

g., Development Safety Update Reports, Investigator Brochure / IB updates, etc.).

Lead global Regulatory Project Team (RPT) and provide oversight for regional regulatory liaisons to execute regional filings in alignment with the global regulatory strategy.

Provide strategic guidance as the Regulatory Affairs Inflammation subject matter expert on cross-functional / cross-regional sub-teams across development (e.

g., Global Development Team, Study Management, etc.) and present to senior leadership as required.

Maintain current understanding of global regulations and proactively assess and communicate their impact on development & registration activities.

Proactively identify regulatory or related risks / issues and develops mitigation and / or contingency plan.

Provide matrix management and leadership to project teams, alongside managing internal and external stakeholders to advance scientific and technical capabilities.

Oversee and guide labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.

Contribute to local and / or global process improvements which have a significant impact on business.

Ensure compliance with established practices, policies, 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.

U.S. Education & Experience

PharmD / PhD with 8+ years’ relevant experience.

MA / MS / MBA with 10+ years’ relevant experience.

BA / BS with 12+ years’ relevant experience.

Extensive regulatory, quality, compliance or related experience supporting medicinal products.

Experience leading New Drug Applications and / or post-marketing NDA expansion activities strongly preferred.

Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion for multiple products.

Experience and proven effectiveness working and negotiating with regulatory authorities.

Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.

Proven track record of effective people leadership and management, successfully leading departmental and cross-functional teams without authority.

Experience working with one or more Gilead therapeutic areas strongly preferred.

Rest of World Education & Experience

BA / BS or advanced degree in life sciences or related field with extensive experience in the biopharma industry, including extensive experience working in regulatory or a related discipline.

Experience leading global MAA filings for one or more regions and / or working extensively with global affiliates strongly preferred.

Knowledge & Other Requirements

Demonstrated advanced knowledge of the drug development process, global and regional regulatory requirements for medicinal products.

Experience leading successful global regulatory filings strongly preferred.

Expert knowledge of all key functions involved in the various stages of drug development from early research through post-marketing.

In-depth knowledge of relevant global health authorities (especially EU, China and Japan), including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting Health Authority interactions.

Able to represent Gilead to regulatory authorities when managing standard and non-standard negotiations.

Strong interpersonal skills, understanding of team dynamics, and communication skills with demonstrated abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.

Strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles.

Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and / or initiatives.

Proven ability to work successfully in a team-oriented, matrixed environment.

When needed, ability to travel.

The salary range for this position is : $205,700.00 - $266,200.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.

These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit :

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States :

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.