Associate Director Regulatory Affairs CMC, Biologics
Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.
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HEALTH AND WELLNESS PROGRAMS
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Employer matching because Sanofi invests in their employees!
Sanofi is eager to further your development and expertise in an ever challenging environment.
Sanofi understands the importance of family. We offer a variety of support including maternity/paternity leave.
PAID TIME OFF
Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!
Importance of life outside of the office is valued at Sanofi.
This position will lead the regulatory strategy for Chemistry Manufacturing and Controls for licensed and clinical biological products; mainly monoclonal antibodies and recombinant proteins. This position will provide product strategy and direction to commercial and clinical teams. Incumbent will be responsible for assuring the 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.
May supervise and coach regulatory professionals and be responsible for their development.
Lead other CMC projects as needed. Experience working in a matrix environment and excellent people skills are required.
Major Activities/Key Responsibilities
- New applications for drugs/biologics
- Plan/Prep/Submit/Review support
- CTA / IND preparation and maintenance
- New Drug BLA/ MAA / International (IMA)
- License Maintenance
- Recurrent filings: annual reports (US, Canadian NDC and YBPR, license and renewals)
- Site renewals (ex. Japan Accreditation)
- Post-Marketing Commitments (PMCs) and Other Regulatory Commitments (ex. Stability data, from CTD text)
- Assemble Information, including assigned deliverables
- Manage regulatory databases
- Communicate to Responsible Parties and Stakeholders on regulatory commitments
- Track Internal Progress and assemble final package
- Submit to Agency/Health Authority/Affiliate and track progress
- Interaction/ liaise with global health authorities on product and CMC topics
- Post Approval Supplements
- Regulatory strategy development
Preparing / Reviewing of Submissions – US, EU and Rest of World (ROW)
- Technical Review of site supporting documents (CoA, declarations, SMF, MBR, SOPs)
- Prepare Response to HA Queries – US, EU and ROW
- Regulatory strategy development
- Change Controls
- Assist change control assessment process
- Track changes 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 a scientific discipline with approximately 5-8 years regulatory experience.
- Biologics RA CMC Experience required.
- Knowledge of USA FDA regulations is essential.
- 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.
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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