Location
Cambridge, MA | United States
Job description
Main responsibilities:
Leads the US regulatory activities.
As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Specialist leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU and/or global regulatory strategy for assigned projects, including Health Authority interactions.
The Regulatory strategist provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
Enables the GRL by providing quality regulatory input and position to internal business partners, including but not limited to the clinical development teams, commercial and Global Regulatory Team for assigned projects
Liaises with clinical, commercial, and other internal business partners in partnership with the GRL to enable successful regulatory outcomes
Contributes to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate committees, forums at the direction of the GRL
Contributes to the GRT for assigned projects in alignment with the team’s one regulatory voice for providing strategic input on the TPP, business planning, governance, and committees. May be requested to lead Global Regulatory Team meetings
May represent GRT strategic position on behalf of the GRL at regulatory forums/committees at request of GRL ((e.g. clinical study team meetings)
May serve as a regional/local regulatory lead and point of contact with Health Authorities for projects/products in their remit, as needed
Identifies regulatory risks and proposes mitigations in collaboration with the GRL, to cross-functional teams working with Sanofi standardized methodologies as appropriate
Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for life cycle management of products
Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to drug and biologics regulations
Ensure that respective regulatory team members have the information necessary to contribute to the development and execution of the Global Regulatory Strategy for their responsible accountabilities
May contribute to the development of global HA interaction strategy in collaboration with non-US – non-EU regions / GRA-CMC / GRA-Devices. Attends HA meetings and collaborates with the regions / GRA-CMC /GRA-Devices to communicate the outcome to senior management as needed
May lead Health Authority meetings and preparations as designated
Leads submission team or regulatory sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for the development and update of the core global dossier / collaborates with regional lead where region-specific submissions are applicable
Leads the IND/ CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation
Ensure that regulatory messaging for regulatory submission documents is aligned with program level and company objectives
Contributes to content and reviews regulated documents (such as IB, PBRER, DSUR, RMP, etc)
Accountable for developing the Health Authority engagement and interaction plans for their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading the team through meeting preparations and moderating the meeting itself for the projects in their remit.
Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, and document management utilizing the support and input of cross-functional team and/or alliance partners where relevant .
Accountable for complete and accurate communication/interaction (including tracking) with the relevant HAs for the projects/products in their remit.
Education:
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) preferred
Experience/Professional requirements:
US regulatory expertise in pre-marketing/development activities required
At least 6 years of prior pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in development phase
Demonstrated experience with preparation of (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing documents and negotiating with a national/regional Health Authority preferred .
Knowledge, Skills & Competencies:
Proactively contribute with curiosity and openness to diverse perspectives
Understanding of clinical development of drugs and/or innovative biologics products
Demonstrated significant leadership experience with driving the preparation of regulatory documents (e.g. (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing documents) and negotiating with a national/regional Health Authority
Emerging business acumen, leadership, influencing and negotiation skills
Ability to use appropriate interpersonal styles and techniques to build internal and external networks and lead discussions with internal and external stakeholders.
Effective communication skills, specifically strong oral and written presentation skills
Lead operational and compliance activities for assigned deliverables, develop, execute and maintain including generating submission content plans, submission tracking, and document management utilizing the support and input of cross-functional team and/or alliance partners where relevant
Experience working in and strong knowledge of electronic document management systems (e.g. Veeva vault, Plai)
Demonstrated ability to handle multiple projects/deliverables simultaneously
Strong sensitivity for a multicultural/multinational 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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