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Submission Associate

Swiftwater, Pennsylvania, Cambridge, Massachusetts, Bridgewater, New Jersey, Toronto, Canada, Laval, Canada

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Overview

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Success Profile

Do you have what it takes for a successful career with Sanofi?

  • Courageous
  • Leadership
  • Proactive
  • Problem-Solver
  • Results-driven
  • Team player

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Culture: Play to Win

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    Growth

  • Scientists discussing lab work

    Innovation

  • Doctor using new technology

    Efficiency

  • Woman using dry eraser marker drawing up business plans on glass

    Collaboration

Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

  • Culture

    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

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Quote

"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."

C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic

"I am continually impressed at the dedication that Sanofi has to the patients for whom we provide solutions."

Suncére Hernandez Area Business Manager, Multiple Sclerosis

"Patients are at the center of our work. Our teams focus on advancing transformational therapies, and expanding patient access to our medicines."

Mouhamed Gueye US Head Medical, Rare Blood Disorders

Responsibilities

Position Overview:

The Submission Associate coordinates lifecycle submissions for the regional portfolio, working directly key stakeholders, GRA focal points and publishing partners to ensure the submissions are prepared on-time and with high quality while meeting HA specifications. They also partner with corresponding Submission Managers and Submission Leads to support the publishing and delivery of complex submission plans.  They have accountability for 3rd party publishing interactions, training, QC and workload prioritization.   The Submission Associate also provides publishing subject matter expertise to project/product teams, special projects and continuous improvement initiatives.

Key Responsibilities:

  • Coordinate lifecycle submission requests for the regional portfolio, working directly with key stakeholders, GRA focal points and publishing partners to ensure the submissions are prepared on-time and with high quality while meeting HA specifications.

  • Partner with GBU and regional submission platforms to achieve and execute GSS plans and delivery, utilizing content re-use strategies and applying technical expertise.

  • Provide guidance to project teams on developing submission structure strategies in accordance with Health Authority and ICH regulations, guidelines and specifications.

  • Collaborate and support third-party vendors as needed to support submission efficiency and overall success.

  • Prepare and compile regional submission documentation to regulatory health authorities according to ICH / eCTD format and submission ready health authority standards, as well as Sanofi standards.

  • Ensure end-to-end process adherence for routine compliance submissions,

  • Perform quality control checks for submission publishing, understanding and addressing validation criteria in detail, and troubleshooting.

  • Assist in improvement efforts of publishing processes and contribute to review and updates of quality documents.

  • Identify and raise submission technical issues in timely manner to ensure that resolutions are realized, enabled and executed to deliver according to planned submission filing dates.

  • Maintain knowledge of regulatory requirements for document and submission assembly and publishing across various submission regions on a continuous basis.

Knowledge, Skills & Competencies / Language:

  • Regional expertise for submission formatting standards, specifications and tools (FDA, Health Canada, EU, ICH).

  • Understanding of global regulatory requirements, global submission processes and the drug development process.

  • Maintain independent abilities to learn quickly and adapt to new technologies/environments. 

  • Self-starter, who motivates and negotiates with an agile and positive approach.

  • Ability to negotiate, influence and cultivate internal and external relationships.

  • Ability to identify critical issues and propose creative and achievable solutions through using appropriate information.  Determines the causes and possible solutions to the problem.

  • Strong attention to detail and accuracy.

  • Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization.

  • Proficiency working in eCTD publishing tools, RIM systems, MS Windows environment and with Windows-based desktop productivity applications (MS Office) including Adobe Acrobat technology is required.

Basic Qualifications:

  • Bachelor’s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience.

  • 3+ years of experience in the pharmaceutical industry, with direct regulatory affairs experience.

  • High degree of technical knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers is required.

  • Working knowledge of drug laws, regulations and guidelines is essential.

  • Ability to work across cultures.

Other Requirements:

  • Strong command of the English language, both spoken and written.

  • Domestic and/or international travel (up to 10%).

  • Ability to operate with agility in a dynamic global environment.

  • Ability to maintain discretion and confidentiality about sensitive data.

  • Ability to communicate and collaborate on many levels, including issue escalation to GRA leadership.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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