Global Regulatory Affairs Lead
Location
Cambridge, MA | United States
Job description
Global Regulatory Affairs Lead (GRL)
Mission statements - The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in Sanofi's diversified portfolio in order to meet corporate and business objectives.
- Decisions are made in alignment with the TA, GBU Head and up to the GRA LT as needed.
- The GRL is the primary interface and key strategic GRA partner for the Global Project Team (GPT) and Global Brand Team (GBT).
Duties & Responsibilities - Accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS), Global Submission Strategy, and core product labeling in development as well as for life cycle management of products
- Responsible for proactively contributing to the Target Product Profile (TPP), ensuring competitive profiles in alignment with the business objectives
- Is accountable for leading the GRT for fostering team performance by aligning team on mission, prioritization, objectives, and setting clear expectations for the Global Regulatory Strategy and Plan, including a global labeling strategy for assigned projects
- The role will supervise, coach, and facilitate a feedback culture within the GRT to develop team performance
- The GRL is expected to develop a team of Regulatory Strategists (RS) as appropriate
- The GRL is 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
- 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
- The role is 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
- Leads development of global HA interaction plan and strategy in collaboration with GRT. Is accountable for the communication of the key outcomes to senior management
- 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
- Accountable for regulatory assessment for Due Diligence activities as applicable through the partnership with GRA Strategy and Business Optimization
Knowledge, Skills & Competencies - Autonomously connects and leverages talent to the advantage of the greater team, with curiosity and openness to diverse perspectives
- Creates a safe environment that inspires creativity, innovation, and productivity
- Is accountable for creating forward-looking vision, influences the environment that optimizes long-term potential by fostering trust and teamwork
- Demonstrates strong business acumen, strong leadership, high level influence and persuasive negotiation skills
- Strong scientific acuity applicable to multiple therapeutic areas
- Expert strategic thinker with experience making complex decisions and defending difficult positions
- Significant leadership experience in developing innovative regulatory strategies supporting the clinical development of drugs and/or innovative biologics products
- Recognized expert using appropriate interpersonal skills to build internal networks and autonomously lead complex negotiations with internal and external stakeholders
- Exemplary communication skills, specifically excellent oral and written presentation skills
- Expert level of organizational savvy; self-motivated and able to work in a highly matrixed structure including sharing knowledge with relevant stakeholders
- Strong sensitivity for a multicultural/multinational environment
- Proven leader of groups and teams
Qualifications - BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) is preferred
- At least 10-12 years of relevant pharmaceutical/biotechnology experience, including at least 10 years of relevant Regulatory Affairs experience (regionally and global), in early and late stage development of multiple modalities
- Demonstrated expert regulatory strategic experience and understanding of the regulatory environment to develop regulatory strategies
- Previous experience working on regulatory due diligence activities and in a business alliance environment
- Demonstrated experience working strategically within a sophisticated, business critical and high-profile development program
- Direct experience formulating the regulatory position in collaboration with the GRT and defending innovative regulatory strategies at Global Project Teams or equivalent forum
- Extensive experience in leading health authority interactions in major markets
- Strategic regulatory leadership expertise with experience in developing and implementing successful regulatory strategy and with preparation of at least one (s)BLA, (s)NDA, or MAA, INDs, Health Authority meeting briefing documents and negotiating with a national/regional Health Authority within a major market (e.g. US, EU, CN, JP)
- Previous demonstrated experience of global regulatory drug development to at least one major regulatory approval within a major market (US, EU) including leading the regulatory strategy, response team, and labeling negotiations
- Previous experience in leading global Health Authority interactions
- Significant project leadership experience
- Significant experience in managing people both directly or in a matrixed organizational structure
- Direct experience with change management/change enabling: leads teams with a solution-oriented mindset in a fast-changing organizational and external regulatory environment
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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