Job title: Regulatory Strategist (RS)

Report to: Global Regulatory Lead (Anu Mahashabde)

Knowledge, Skills & Competencies:

• Proactively contribute with curiosity and openness to diverse perspectives

• Understanding of clinical development of drugs and/or innovative biologics products

• Demonstrated 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

Qualifications :

• 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

• 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

• Experience with clinical development of drugs and/or innovative biologics products

• 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

• Experience on multidisciplinary matrixed project teams (e.g. clinical study team) preferred.

• Project Leadership experience preferred.

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-SA
#LI-SA

PDN

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!