COMPLETE Global Regulatory Lead - Transplant - Mississauga, ON

ABOUT THE JOB

Our team

Sanofi Transplant franchise is committed to going above and beyond to enable the success of Therapeutic Area development programs. The Global Regulatory Lead (GRL) for Transplant will have an instrumental role in leading the associated regulatory strategy development for novel therapies and therefore empower patients and providers and fundamentally improve the lives of transplant patients.

In that context, GenMed organization is looking for a bold and innovative team leader to join Transplant Therapeutic Area. Bring you expertise, leadership and innovative mindset and join us on our journey to build a robust and sustainable business environment for General Medicines GBU Transplant Franchise.

Main responsibilities

The GRL is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for Transplant development programs, i.e. the GRL will be

• Accountable for leading the development and execution of innovative and value-added global regulatory strategies including Global Submission Strategy for Transplant Franchise key asset (e.g. Marketing Authorizations, extension of indications, IND/CTA, PIP/PWR, Scientific Advices, etc.)

• Accountable for ensuring alignment and communication internally and externally as “one GRA voice” with TA, GBU Head and up to the GRA LT when needed to advocate regulatory position to governance and committees and shares outcomes to GRT and cross-functional partners as appropriate

• Accountable for leading the GRT for fostering team performance by aligning team on mission, prioritization, objectives, and setting clear expectations in line with business priorities

• Develop and guide a team of Regulatory Strategists (RS). A team of (2 to 5) regulatory strategists will be reporting to the GRL

• Identify opportunities to support the team to identify regulatory acceleration opportunities, take thoughtful risks, accept challenges, and making final decisions on the regulatory success rates and mitigations on behalf of the GRT

• The GRL is the single GRA point of contact for the program and represents GRA at the GPT/GBT and internal governance committees

• Advances the organization’s goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned therapeutic area and projects in collaboration with the Regions

• Responsible for assessing and interpreting the global regulatory and competitive environments and accountable to ensure that it leverages expertise in commercial competitive intelligence and other parts of GRA (e.g. Regional experts and Regulatory Science and Policy) in order to ensure the most robust strategy possible and is accountable for determining any updates to the regulatory strategy accordingly

• Accountable for regulatory assessment for Due Diligence activities as applicable through the partnership with GRA Strategy and Business Optimization

ABOUT YOU

Qualifications/Education & work experience

• Bachelor's degree or advanced degree in science

• Strong (10+ years) of experience in Regulatory Affairs including global development projects

• Direct interaction/negotiation with major Health Authorities’ (EMA, FDA) and experience with registration of medicinal products via centralized procedures

• Experience with acceleration pathways (Orphan Drug, Breakthrough Therapy, etc.), pediatric and clinical trial regulations as well as novel methodologies for regulatory decision making (RWE, patient focused drug development, etc.)

• People management and development

• Strong strategic skills including the ability to make complex decisions and ability to defend difficult positions

• Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans

• Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities

• Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi P2W values

Possible locations

• Worldwide with a preference for United States, France and Netherlands

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.