Manager, Regulatory Submission Management

Gilead Sciences•Parsippany, NJ

1d•$123,930 - $176,440•Hybrid

About The Position

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. At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. Regulatory Submission Management acts as a partner for strategic planning and execution of the portfolio, to ensure global Regulatory submissions are scalable, seamless, and optimized. We are a trusted companion across Regulatory Affairs, bridging strategy and execution while building knowledge across the portfolio to bring therapies to patients faster, together. You will execute a wide range of regulatory submissions independently, including submissions of high complexity, contribute to global submission content plans, and lead review and planning processes for multiple products or projects. You will represent Regulatory Submission Management (RSM) on relevant product, project, and/or regulatory submissions teams, providing specialist guidance on regulatory submissions requirements and timing. You may also represent RSM on other cross-functional initiatives. You will plan and have oversight for assigned deliverables and may serve as the RSM lead for small to medium regulatory submissions. You will participate in identifying/developing process improvements, new standards, and updating systems in support of submissions. You may coach, train, and provide guidance to less experienced RSM colleagues.

Requirements

6+ Years with BS/BA OR 4+ Years with MS/MA
BA/ BS with 6+ relevant submission management, regulatory project management or regulatory operations experience in the biopharma industry, or 4+ years’ relevant experience with MA/MS/MBA, or 0 years’ relevant experience with PharmD/PhD.
Significant experience in the biopharma industry is strongly preferred.
Experience managing a broad range of submission types across multiple stages of drug development.
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.
In-depth knowledge of relevant health authorities, including system, processes and regulatory requirements.
In-depth knowledge of regulatory document requirements and guidelines relevant to assigned products, projects, and markets, as evidenced by effectiveness and successes with technically compliant and rapid filings.
Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, Smartsheet and Sharepoint as evidenced through accomplishments in past roles.
Ability to lead and influence submissions, projects and/or initiatives.
Strong interpersonal skills and understanding of team dynamics.
Proven ability to work successfully in a team-oriented, highly matrixed environment.

Nice To Haves

Experience working with one or more Gilead TAs and varying stages of drug development is strongly preferred.
Recognized as a SME in a broad range of regulatory submission types and a resource for technical advice and guidance.
Able to advise cross-functional partners on technical health authority requirements and RSM processes to meet business goals and objectives.
Able to advise cross-functional partners on technical health authority requirements and processes to meet business goals and objectives.
When needed, ability to travel.

Responsibilities

Manages a wide variety of global submissions, such as clinical study reports (CSRs), investigator’s brochures, DSURs, regulatory responses, original INDs and amendments.
May represent RSM in cross-functional teams, such as product, project and/or regulatory submissions teams; providing guidance for optimal strategies to achieve speed-to-filing or meet technical health authority requirements; may act as a technical and operational lead for submission execution.
Plans and oversees assigned submissions with responsibilities including development and management of global and regional content plans and resource planning for assigned submissions.
Acts as a Subject Matter Expert for various expertise related to RSM Core Capabilities
Supports regulatory maintenance activities for early development and late-stage products.
Supports the planning and preparation activities of regulatory deliverables with direction from an RA Liaison and/or GRAD Affiliate
May serve as the RSM lead for small to medium regulatory submissions.
May serve as lead submission manager and department representative across development programs.
Organizes preparation of high-quality documents for internal stakeholders.
Author documents and/or procedures for submissions such as cover letters, forms and other documents as assigned.
Participates in development/improvement of submission standards, submission templates, and validation decision trees.
May also participate in other special projects and/or represent RSM in other cross-functional initiatives.
Where applicable, oversees the work of external contractors supporting deliverables and other activities.
Act as the primary interface with the publishing team to plan and negotiate publishing timelines and deliverables.
May coach, train, and provide guidance to less experienced Submission Management colleagues.
Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.