Sr Manager, Regulatory Affairs - Virology

* 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.
* 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
* 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.

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:
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