Head, Americas Submission Platform

Job type: Full-Time
Accepting BioReady™: Yes
Category: Information Technology
Employer: Sanofi
Location: Various, ON
Posted: September 22, 2022
Closes: October 22, 2022

Job description:

Mission statements

The Head, Americas Submission Platform is a leader with first line accountability for the quality, accuracy and timeliness of regulatory submissions for Sanofi’s North American and LATAM core package portfolio.   This role is responsible for setting the vision for assigned team and collaborating with GRA and GRO leadership to set goals, drive process efficiencies and overall operational effectiveness for regulatory submissions.

DUTIES & RESPONSIBILITIES

Direct Submission Management Activities:

• Direct the GRO activity for Sanofi GRA’s America’s submissions portfolio, with first line accountability for managing the submission forecast and ensuring proper staffing for upcoming submissions.

• Ensure staff is delivering high quality and timely submissions to global regulatory health authorities which are aligned to both Sanofi and Health Authority standards.

• Create and manage a strategic resourcing model, leveraging support from 3rd parties to balance workload.

• Lead staff with interpretation of global regulatory guidelines and approve processes, procedures and submission templates to ensure compliance with internal/external requirements.

• Collaborate with leadership in GRO, GRA and R&D contributing groups to understand the global regulatory environment for Sanofi products and develop appropriate action plans for GRO.

• Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring GRO staff.

Drive Operational Effectiveness:

• Ensure staff adherence to the appropriate use of technical tools to ensure regulatory and internal compliance is preserved.

• Define and implement standards and process efficiencies for submission publishing and design effective change-management communications.

• Write, review and/or approve process documentation, including SOPs and Policy documents.

• Collaborate with GRO leadership to develop departmental metrics and performance goals/KPIs and monitor progress regularly.

• Oversee the continuous improvement, development and integrity of GRO systems and procedures.

• Support legal requests, M&A integrations, product divestments, audits/inspections and related entities.

• Forecast and manage to the Submissions Management budget.

• Provide Subject Matter Expertise for technical publishing tools.

• Lead and/or represent GRO in GRA special initiatives.

Performance Management:

• Mentor employees/consultants.

• Interview, hire and train employees/consultants.

• Manage direct reports’ performance by setting clear objectives and development goals, providing frequent feedback and conducting performance assessments.

• Manage 3rd party partner performance and workload.

Knowledge, Skills & Competencies / Language:

• Proven success in leading teams and people management.

• Strong understanding of global regulatory requirements and submission processes.

• Self-starter, who motivates, has tact, diplomacy, leadership skills and a flexible and positive approach.

• Demonstrated leadership ability, with strong negotiating and influencing skills.

• Ability to lead complex projects and timelines in a matrix team environment.

• Ability to identify critical issues and understand complex 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.

• Demonstrated project management skills, with the ability to integrate planning efforts across departments to ensure organizational effectiveness.

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

• Ability to cultivate internal and external relationships.

• Understanding of Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines.

• Applicable knowledge of the drug development process.

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

QUALIFICATIONS

• At least a bachelor’s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience

• Experience in the pharmaceutical industry with at least 10 years of regulatory affairs experience. High degree of knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers is required.

• Past experience in regulatory operations is preferred.

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

• Ability to work across cultures

REQUIREMENTS OF THE JOB

• this position requires some domestic and international travel

• this position will suit an individual who is able to operate with discretion and confidentiality about sensitive data

• this position requires leading cross-functional teams and interactions with external partners

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.

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.

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

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

#GD-SA

#LI-SA

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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