Sr Manager, Regulatory Affairs - Virology

Gilead Sciences, Inc.•Parsippany, NJ

38d•$143,225 - $203,940

About The Position

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.

Requirements

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

Nice To Haves

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.

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.

Benefits

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

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