Sr Manager, Regulatory Affairs - Virology

Job Description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s 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 we’re 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 typically act as the Regional Regulatory Lead on the assigned products, compounds, indications or projects in Virology. With guidance, you will define the regulatory strategy, plans and objectives for the assigned products or projects. You will typically lead the Regulatory Submissions Teams associated with assigned products or projects and represent Global TA Regulatory to cross-functional sub-teams. You may serve as a Gilead contact to / for regulatory authorities. You will oversee and manage the work of less experienced colleagues supporting your work. You will coach and advise less experienced colleagues in completing their work and developing their regulatory capabilities. You will typically be assigned products, compounds, indications or projects of increasing complexity. You will also typically play a more active role in process improvements and other special projects that can carry significant value to multiple Regulatory Affairs activities and teams.

Position will be filled in either Foster City, CA or Parsippany, NJ.

EXAMPLE RESPONSIBILITIES:

• Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams.
• Participates on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers).
• With guidance, defines the regulatory strategy for one or more Gilead products or projects.
• Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plans.
• Leads 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.).
• Leads cross-functional teams in the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc.
• Provides input to the content of the original label and label updates.
• Ensures product packaging and associated information is updated and maintained in accordance with the product license for assigned products and markets.
• Critically reviews documents for submission to regulatory authorities.
• Initiates or otherwise contributes to process improvements and/or other special projects within Regulatory Affairs.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

Basic Qualifications:

• Doctorate and 2+ years of relevant experience OR
• Master’s and 6+ years of relevant experience OR
• Bachelor’s and 8+ years of relevant experience OR

Preferred Qualifications:

• Significant regulatory, quality, compliance or related experience supporting medicinal products.
• Significant regulatory experience in the biopharma industry is strongly preferred.
• Experience setting the regulatory strategy and leading regulatory submissions and other activities for a medicinal product is strongly preferred.
• Experience successfully leading departmental and cross-functional teams without authority.
• Experience authoring and implementing processes.
• Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.

• 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 advanced knowledge of regulatory requirements and the role of regulatory affairs in achieving cross-functional drug discovery and development goals and objectives, including ICH standards and the regulatory requirements for assigned markets.
• In-depth knowledge of relevant health authorities, 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 or more routine negotiations.
• Demonstrates 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.
• Ability to lead and influence programs, projects and/or initiatives.
• Strong interpersonal skills and understanding of team dynamics.
• Proven ability to work successfully in a team-oriented, highly-matrixed environment.
• When needed, ability to travel.

The salary range for this position is:

Bay Area: $157,590.00 - $203,940.00.

Other US Locations: $143,225.00 - $185,350.00.

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:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , 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 [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.