Regulatory Submission Lead
- 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.
- 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
- 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.
- 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
- 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.
#LI-SA #LI-Onsite
#vhd 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.
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