The incumbent leads and coaches a team of regulatory professionals including line management/direct supervision, people development and mentoring, and depending on the number of direct reports, may also have the responsibility to manage a portfolio of projects/products.
Accountable to endorse the global regulatory CMC strategies for the portfolio of projects/products managed by his/her team (development projects and/or marketed products within GRA CMC & Devices Departments, in Small Molecules Marketed, Small Molecules Development, Consumer Health Care Products, Biologics, and Vaccines).
The incumbent will support his/her team members in developing innovative Regulatory Strategies acceptable for Health Authorities, and oversees Global Regulatory Strategy, ensuring it is aligned with Health Authorities expectations. Expected to organize and lead contacts with Regulatory Agencies, including FDA/EMA.
The incumbent will lead the project/product strategy and oversee the direction to R&D Development and Pharma Operation teams.
Creates collaborative working relationships with Global Regulatory Affairs (GRA, Corporate, Regions and Country Regulatory Groups), Technical and Quality Groups within R&D and Industrial Affairs, External Alliance Partners, Project Direction/Management (R&D Development, Innovation, Pharma Operations teams), Human Resources, Legal, Finance, Regulatory Health Authorities, Others. The incumbent is also engaged in internal and external Regulatory Policy Organizations/Programs in order to develop and maintain appropriate Sanofi representation in these activities.
The incumbent demonstrates behaviors that live and promote the Sanofi and GRA Values/Principles/Competencies.
Duties & Responsibilities
Management of a team of regulatory professionals and provides input, as appropriate, to the team's Global Regulatory CMC strategies. Challenges or support team proposals or request for Regulatory strategy Assessment for internal or external review of the CMC strategies. Ensure Recommendation from Regulatory CMC & D LT are communicated, understood and implemented, and escalate CMC regulatory or technical issues to management for decisions or endorsement of strategies
Develops Global Regulatory CMC strategies and risk assessments for development projects and/or marketed products (new or marketed chemical entities, biological entities, vaccines and/or consumer health care products) in collaboration with other parts of GRA. Assures effective involvement with change control systems. Assures that his/her team develops positive and collaborative relationships with CMC teams to achieve the implementation of appropriate regulatory strategies. Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated and mitigated as necessary.
Assures appropriate contacts with Health Authorities are initiated and addressed in an effective and timely manner, whilst developing positive and favorable relationships with Health Authorities. Supports strategic negotiations with worldwide Regulatory Health Authorities, including directly with FDA and EMA for specific CMC topics, so that appropriate and pragmatic positions are negotiated with the highest Probability of Success (POS).
Supervise (and manage when he/she has project/product responsibliity) or directly contribute to the CMC writing, preparation, review and approval of regulatory CMC dossiers for submission in collaboration with R&D Functions, Industrial Affairs Functions and GRA Regulatory Operations, and ensures tracking and resolution of CMC Post approval Commitments. Ensures that the submission dossiers are prepared according to timelines, requirements, and meet appropriate quality standards; Supervise the devlopment of Global Regulatory CMC Strategy Document, in line with Blue Print. Assures that technical and regulatory CMC issues are appropriately resolved with optimal solutions. As applicable, support the regulatory inspection process for development projects and marketed products.
Contributes knowledge and expertise on GRA Regulatory Science and Policy activities, as well as other related internal or external policy initiatives, in order to assure that appropriate Sanofi visibility and input is recognized. Monitors the review of local and international Health Authority regulations and guidelines, contributes to the commenting process and/or develops position papers. Assures that current Health Authority thinking and trends (paradigm shifts) are understood and broadly communicated.
Knowledge, Skills & Competencies / Language
Global operational experience with a mid/large-size Regulatory CMC and Devices Organization.
Must have broad knowledge of global regulations/guidelines, of key Health Authority/Industry thinking and trends (at least, FDA , EMA, or MLHW and International regulations/guidelines) , and be capable of resolving strategic technical and regulatory issues.
Leadership, team work and communications skills, to be in the position to manage a team and to present and support CMC Regulatory strategies at Senior Management Committees or during meetings with Health Authorities.
Ability to work in a complex matrix environment.
Fluency (oral and written) in English language is essential.
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.
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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