Job Title: Regulatory Submission lead
Location: Morristown, NJ/ Cambridge MA
About the Job
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.
The Submission Lead is responsible for the planning, co-ordination and tracking of regulatory submission activities for assigned programs at Sanofi. The Submission Lead is a senior team member with the expectation and accountability to drive Global Simultaneous Submission (GSS) filing execution plans for Sanofi's priority portfolio. The Submission Lead is also the GRO Submissions Management focal point for Mergers & Acquisitions integration and Joint Venture project teams and is directly involved in relationship building, ensuring achievement of business goals and protecting business continuity
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?
Main Responsibilities
Submission Management Activities:
Act as key partner to the GRL and project teams by applying global submissions management expertise in the design, planning and delivery of the GSS filing plans for Sanofi R&D's priority growth assets.
Represent GRO on the Global Regulatory Teams for Sanofi GBU priority assets, per the GRA BluePrint model.
Act as Project Leader for the GRO Submissions Management Task Force (SMTF), managing global colleagues in a matrix environment to ensure alignment, visibility and timely delivery across all platforms for the GSS filings.
Accountable for the delivery of high quality and timely submissions to global regulatory health authorities which are aligned to both Sanofi and Health Authority standards. Provides analysis, tracking, communication and issue escalation/resolution on overall operational activities based on input from technical experts (Submission Managers, Submission Associates and/or Publishers).
Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted
Act as Regulatory Operations Team expert providing subject matter advice on ICH, eCTD, and electronic submission requirements, as well as other pertinent regulatory guidelines relating to the format of regulatory submissions.
Remain fluent and current on global regulatory guidelines and approval processes, procedures and submission templates to ensure compliance with internal/external requirements.
Direct and mentor trainees and interns.
Partner and support Submissions Management Leadership in the management of GRO activity for Sanofi GRA's priority submissions portfolio, the submission forecast and ensuring proper staffing for upcoming submissions.
Create and manage resourcing and budget plans, as needed.
Submission Partnerships and Integrations
Act as a key contact in managing complex joint ventures and designing e-submission strategies between the companies.
Ensure that the team follows and strictly adheres to, internal standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the lifecycle of the application.
Coordinate with Regulatory Operations external equivalent to develop milestones and timelines and ensures success in obtaining goals and ensuring business continuity.
Act as focal point on M&A integration project teams to build relationships, develop timelines and achieve milestones to protect business goals and business continuity. Partner closely with GRO colleagues on integration plans.
Provide oversight and manage vendors to support Regulatory submissions goals and integration timelines
Drive Operational Effectiveness:
May assist in the writing and review of process documentation, including SOPs and Policy documents.
Oversee the continuous improvement, development and integrity of GRO systems and procedures.
Lead and/or represent GRO in GRA special initiatives.
About You
Requirements
Bachelor's degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience
6+ years of experience in the pharmaceutical industry, with direct regulatory affairs experience.
High degree of knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers
Project management experience is preferred.
Working knowledge of drug laws, regulations and guidelines is essential.
Ability to work across cultures
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.
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.
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
