Regulatory Strategist

About the role

Brings regulatory expertise to shape the future of medicine. Works at the intersection of lab science and AI-powered discovery, collaborating across boundaries to drive breakthroughs.

Main Responsibilities

• Provides quality regulatory input and position to internal business partners, including clinical development teams, commercial, and GRT for assigned projects.
• Contributes to the GRT for assigned projects in alignment with the team's one regulatory voice for strategic input on the Target Product Profile (TPP), business planning, governance, and committees.
• Develops the Global Regulatory Project Strategy (GRPS) and ensures alignment with core product labeling for products in development and lifecycle management.
• Serves as a regional/local regulatory lead and point of contact with HAs for projects/products in their remit, as needed.
• Led HA engagement and interaction plans for assigned products, including authoring briefing documents focused on strategy and scientific content, leading team through meeting preparations, and moderating meetings.
• Leads submission teams or regulatory sub-teams to ensure NDA/BLA/MAA/Extensions filings meet project timelines for product launch and develops core global dossiers, collaborating with regional leads where region-specific submissions are applicable.
• Leads IND/CTA submission strategies to ensure preparation timelines meet project timelines for clinical trial initiation.
• Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, and document management, utilizing support and input of cross-functional teams and/or alliance partners where relevant.

About You

• Minimum 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 relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regional and global), in early and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable.
• Demonstrated experience with preparation of (s)BLA/(s)NDA/MAA, INDs/CTAs, HA meeting briefing documents and negotiating with a national/regional HA preferred.
• Experience on multidisciplinary matrixed project teams (e.g. clinical study team) preferred.
• Project leadership experience preferred.

Why Choose Us

• Supportive, future-focused team environment.
• Incredible opportunities for growth and development.
• Comprehensive rewards package recognizing contributions and amplifying impact.
• Comprehensive health and wellbeing benefits.
• Pioneering biopharma company engaged with patients early in drug development.
• Use of cutting-edge AI, data, and digital platforms to push boundaries of science.
• Commitment to improving the lives of millions of people globally.
• Equal opportunity and affirmative action employer.