Regulatory Strategist

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.
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