Regulatory Strategist

Regulatory Strategist

• Location: Cambridge, MA
• Remote Work: Hybrid
• Job Type: Full Time
  
  

About The Job

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Are you 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. 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) , the Regulatory Strategist (RS) leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU and/or global regulatory strategy for assigned projects, including Health Authority interactions.

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 Global Regulatory Team for assigned projects
• Liaises with clinical, commercial and other internal business partners in partnership with the GRL to enable successful regulatory outcomes
• Contributes to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate committees, forums at the direction of the GRL
• Contributes to the Global Regulatory Team (GRT) for assigned projects in alignment with the team’s one regulatory voice for providing strategic input on the TPP, business planning, governance and committees. May be requested to lead Global Regulatory Team meetings
• May represent GRT strategic position on behalf of the GRL at regulatory forums/committees (e.g.  clinical study team meetings)
• May serve as a regional/local regulatory lead and point of contact with Health Authorities for projects/products in their remit, as needed
• Identifies regulatory risks and proposes mitigations in collaboration with the GRL, to cross-functional teams as appropriate
• Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for life cycle management of products
• Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to drug and biologics regulations
• Ensure that respective regulatory team members have the information necessary to contribute to the development and execution of the Global Regulatory Strategy for their responsible accountabilities
• May contribute to the development of global HA interaction strategy in collaboration with non US– non EU- regions / GRA-CMC / GRA-Devices. Attends HA meetings and collaborates with the regions / GRA-CMC /GRA-Devices to communicate the outcome to senior management as needed.
• May lead Health Authority meetings and preparations as designated
• Leads submission team or regulatory subteam 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
• Ensure that regulatory messaging for regulatory submission documents is aligned with program level and company objectives
• Contributes to content and reviews regulated documents (such as IB, PBRER, DSUR, RMP, etc)
• Accountable for developing the Health Authority 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.
• 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
• Collaborate with key functions throughout the Sanofi Vaccines and Sanofi Group organizations, such as External R&D, Alliance Management, Early and Late Development Portfolio Groups, Chief Scientific Officer, etc.
• Collaborate with the Global Head by providing scientific guidance and direction in their field of expertise in the development of the Global R&D Innovation Roadmap and innovation priorities
• Identify and engage potential collaborators, develop the project workplan and budget in collaboration with external partners and the relevant vaccine R&D functions.
• Lead >1 project per year.  Develop the project deliverables, risks, and Go/No Go decisions.  Through their leadership, drive the innovation project through defined milestones in collaboration with the external partner.

About You:

• 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 (regionally 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, 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
• 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

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused 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.

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, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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


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!

#GD-SA  ​
#LI-SA​

#LI-Onsite​