Sanofi Group Senior Associate, Regulatory Affairs CMC Biologics in Framingham, Massachusetts
Based in our Framingham office, 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.
In this role, you are expected to provide support for other CMC projects as needed. In order to be successful, experience working in a matrix environment and excellent people skills are required. There will be close collaboration with other GRA colleagues (including GRA Regions and country Regulatory Teams), Technical, Quality and Project Management Teams within Industrial Affairs and R&D.
Major Activities/Key Responsibilities
New applications for biologics
Plan/Prep/Submit/Review support for product dossiers including territory extensions;
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)
Notify Reg Ops for publishing and dispatch
Response to Health Authority (HA) Queries – US, EU and ROW
Interaction / liaise with HAs on CMC topics
Global Regulatory CMC Strategies and risk assessments for development projects and/or marketed products in collaboration with other parts of GRA. Assures positive and collaborative relationships with CMC teams to achieve implementation of appropriate regulatory strategies.
Change control assessments
Initiate change in regulatory database and follow-up with local regulatory representatives on the assessments of the change.
To excel in this role you will need to have:
Bachelor’s or Master’s degree in Healthcare & Life Sciences, e.g.: Pharmaceutical Sciences, Biology, Chemistry;
3-5 years of relevant work experience in a highly regulated industry; knowledge of EU, FDA and global regulations for biological products required;
Fluent in spoken and written English.
Analytical, accurate with an eye for detail;
Good scientific writing skills;
Proficient in MS Word, Excel, PowerPoint, MS Project, and IT Systems;
Excellent organizational, communication (written and verbal) and negotiation skills;
Demonstrated ability to work successfully on project teams.
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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life