Job title: Regulatory Strategist
- Location: Morristown, NJ / Cambridge, MA
About the JobAs
Regulatory Strategist within our
R&D team, you will be ready to shape the future of medicine. The race is on to speed up drug discovery and development to find answers for patients and their families, and your skills could be critical in helping our teams accelerate progress.
As a key member of the Global Regulatory Team (GRT) and strategic partner to the Global Regulatory Lead (GRL), you will leverage your regulatory expertise to contribute to the definition of the global regulatory strategy and drive the execution of aligned US, EU, and/or global regulatory strategies for assigned projects, including Health Authority (HA) interactions. You will provide regulatory expertise and guidance on procedural and documentation requirements to the GRT and cross-functional teams, working flexibly within and across regions to ensure the delivery of business objectives.
Main Responsibilities- Enables the GRL by providing quality regulatory input and position to internal business partners, including but not limited to the clinical development teams, commercial and GRT for assigned projects.
- Contributes to the GRT for assigned projects in alignment with the ream's one regulatory voice for providing strategic input on the Target Product Profile (TPP), business planning, governance and committees. May be requested to lead GRT meetings.
- Contributes to the development of the Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for lifecycle management of products.
- May serve as a regional/local regulatory lead and point of contact with HAs for projects/products in their remit, as needed.
- Accountable for developing the HA engagement and interaction plans for their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading the team through meeting preparations and moderating the meeting itself for the projects in their remit.
- May lead HA meetings and preparations as designated.
- Leads submission team or regulatory sub-team to ensure NDA/BLA/MAA/Extensions filings meet the project timelines for product launch and is responsible for the development and update of the core global dossier/collaborates with regional lead where region-specific submissions are applicable.
- Leads the IND/CTA submission strategy to ensure preparation timelines meet the 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 the support and input of cross-functional team 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- Bring the miracles of science to life alongside a supportive, futurefocused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.
The salary range for this position is:
$148.500,00 - $214.500,00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
