CMC Regulatory Lead

Job description

Job Description

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 positive and collaborative relationships are developed 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 that appropriate contacts with Health Authorities , in collaboration with Country Regulatory Groups , are initiated and addressed in an effective and timely manner, whilst developing positive and favorable relationships. Responsible for direct contact/liaison with US FDA and EMA on specific CMC topics. Supports strategic negotiations with worldwide Regulatory Health Authorities so that appropriate and pragmatic positions are negotiated with the highest Probability of Success (POS).

Manages or directly contributes 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. Assures that submission dossiers meet appropriate quality standards; strategies and mitigated risks are developed and communicated, and deadlines are achieved. 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.

Major Activities/Key Responsibilities

·  New applications for biologics
·  Plan/Prep/Submit/Review support for product dossiers
·  CTA / IND preparation and maintenance
·  License Maintenance
·  Recurrent filings: annual reports (US, Canadian NDC and YBPR, license and renewals)
·  Site renewals (ex. Japan Accreditation)
·  Post Approval Supplements
·  Regulatory strategy development
·  Preparing / Authoring / Review of Submissions – US, EU and Rest of World (ROW)
·  Technical Review of site supporting documents (CoA, declarations, SMF, MBR, SOPs)
·  Notify Reg Ops for publishing and dispatch to BoH
·  BoH Response to Queries – US, EU and ROW
·  Interaction / liaise with EMA and EU member state BoH on CMC topics
·  Post Approval Supplements
·  Regulatory strategy development
·  Preparing / Authoring / Review of Submissions – US, EU and Rest of World (ROW)
·  Technical Review of site supporting documents (CoA, declarations, SMF, MBR, SOPs)
·  Notify Reg Ops for publishing and dispatch to BoH
·  BoH Response to Queries – US, EU and ROW
·  Change Controls
·  Change control assessments
·  Initiate change in regulatory database and follow-up with local regulatory representatives on the assessments of the change.
·  Provide interpretive analyses regarding impact of complex regulatory guidance documents, regulations, or directives that impact company products and operations.

Qualifications

Basic Qualifications:

·  University degree in scientific discipline with 3-5 years regulatory experience.
·  Knowledge of FDA regulations is essential.
·  Experience with biological products

Preferred Skills:

·  Proficient in MS Word, Excel, PowerPoint, MS Project, and Trackwise.
·  Excellent organizational and communication (written and verbal) skills.
·  Demonstrated ability to work successfully on project teams.
·  RAC certification preferred.
·  Previous experience working in a fast paced environment on multiple product lines
·  Manufacturing, QA/QC experience

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.

#GD-SG

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.