Sanofi Group Senior Associate, Global Regulatory Affairs, CMC Biologics in Waltham, Massachusetts
Job Description :
This position will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for licensed and clinical biologic products. This position will provide input into the product strategy and to the direction provided to commercial and clinical teams. Incumbent will be responsible for assuring the established regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality.
Additional duties include coordination with our global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management.
Provide support for other CMC projects as needed.
Experience working in a matrix environment and excellent people skills are required.
Major Activities/Key Responsibilities:
New applications for biologics
Plan/Prep/Submit/Review support for product dossiers
CTA / IND preparation and 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
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.
University degree in scientific discipline with at 3years regulatory experience or relevant industry experience.
Knowledge of FDA regulations is essential.
Experience with biological products is a plus
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 is a plus
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.