Manager, Regulatory Ops- Submission Management

Getting Hired; Cambridge; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading biopharmaceutical company in Cambridge is seeking a Manager of Regulatory Submission Management to oversee submission execution for a wide variety of global projects. The successful candidate will manage complex submissions, support regulatory planning, and ensure compliance with regulations. With a BA/BS as a minimum requirement and significant experience preferred, this role demands strong analytical skills, attention to detail, and proficiency with Veeva and other tools. The company fosters a collaborative environment aimed at improving health outcomes.

Qualifications

• Experience in submission management or regulatory operations in biopharma.
• Significant experience in the biopharma industry preferred.
• Familiar with content planning for various submission types.

Responsibilities

• Manage global submission projects with various complexities.
• Support regulatory portfolio planning and submission execution.
• Oversee assignment of submissions and resources.

Skills

Submission management

Regulatory operations

Content planning

Analytical thinking

Interpersonal skills

Education

BA/BS in relevant field

MA/MS/MBA or equivalent

PharmD/PhD

Tools

Veeva

Microsoft Office

Smartsheet

SharePoint

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.

Job Description

Manager, Regulatory Submission Management

Regulatory Submission Management (RSM) 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 (RA), bridging strategy and execution while building knowledge across the portfolio to bring therapies to patients faster, together.

This role is focused on submission planning and execution. You will execute a wide range of regulatory submissions independently, including submissions of high complexity, contribute to and manage global submission content plans, and lead review and planning processes for multiple products or projects. You will represent 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 an RSM lead for regulatory submissions. You will participate in identifying and developing process improvements, new standards, and updating systems in support of submissions. You may coach, train, and provide guidance to less experienced RSM colleagues.

Essential Duties and Job Functions:

• Manages the submission execution activities for a wide variety of global submission projects, such as clinical study reports (CSRs), variations, investigator’s brochures, DSURs, regulatory responses, original INDs and amendments.
• May support regulatory portfolio planning activities or submission execution for multiple submissions of varying complexity including global marketing applications.
• Represents RSM in cross‑functional teams, such as product, project and/or regulatory submissions teams; providing guidance for technical strategies to achieve fast frictionless filings 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.
• Supports the planning and preparation of maintenance activities for early development and late‑stage regulatory deliverables with direction from RA Liaisons.
• Organizes preparation of high‑quality documents 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 RSM colleagues.
• Ensures work complies with established practices, policies, and processes, and any regulatory or other requirements.

Education & Experience:

• BA/ BS with relevant submission management, or regulatory operations experience in the biopharma industry, or relevant experience with MA/MS/MBA, or relevant experience with PharmD/PhD.
• Significant experience in the biopharma industry is strongly preferred.
• Experience with content planning for a broad range of submission types across multiple stages of drug development utilizing Veeva.
• Experience working with one or more Gilead TAs (Virology, Inflammation and Oncology) and varying stages of drug development is strongly preferred.

Knowledge & Other Requirements

• 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.
• 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.
• Knowledge of Veeva content planning and publishing best practices and tools with proven ability to apply these to improve submission efficiency and effectiveness.
• Demonstrates strong analytical thinking skills, attention‑to‑detail, strong communication and writing skills, project management skills and proficiencies with Veeva, DocuBridge, Microsoft Office suite, Smartsheet and SharePoint as evidenced through accomplishments in past roles.
• Ability to lead and influence submissions, projects and/or initiatives.
• 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.
• 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.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company‑sponsored training, education assistance, social and recreational programs are administered on a non‑discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.