Submission Associate

Missionstatement

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.

Duties & 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.

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.

Requirementsof the job

• 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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PDN

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health.This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

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.