GBU Submission Management Dossier Lead (RA)
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The Regulatory Dossier Lead is responsible for the planning, co-ordination and tracking of regulatory GBU portfolio submission activities for assigned programs at Sanofi. This position ensures optimal expertise on all dossier formats, standards, navigation, and life cycle management globally.
The GBU Submission Management Team is committed to fostering a team culture of ownership and accountability including continuous evaluation to drive operational effectiveness for regulatory submissions. This culture extends to our engagement and collaboration within GRA and with cross-functional stakeholders and external partners.
Duties & Responsibilities:
Submission Management Activities:
- Responsible for leading the planning and delivery of worldwide regulatory submissions required to support the development and registration of new global products.
- Represent GRO Submissions Management in the development of global submission filing plans and actively participating in Global Regulatory Product Teams as part of the GRA Blue Print model.
- Acts 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.
- Leads creation and maintenance of submission plan (eTOC), based on a thorough understanding of publishing tools and processes.
- Leads project teams to ensure the control of submission component receipt and workflow completion
- Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted
- Ensure delivery of high quality and timely submissions to global regulatory health authorities which are aligned to both Sanofi and Health Authority standards.
- Remain fluent and current on global regulatory guidelines and approval processes, procedures and submission templates to ensure compliance with internal/external requirements.
- Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring GRO peers
- Provide oversight and manage vendors to support Regulatory submissions goals.
- Act as a key point of contact for leadership in establishing trusting partnerships with external co-developer pharmaceutical companies for implementation of e-Submission strategies between two 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.
Drive Operational Effectiveness:
- Support in the implementation of standards and process efficiencies for submission publishing and support effective change-management communications.
- 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.
Knowledge, Skills & Competencies / Language:
- Strong understanding of global regulatory requirements and submission processes.
- Self-starter, who motivates, has tact, diplomacy, and a flexible and positive approach.
- Ability to lead projects and timelines in a matrix team environment.
- Strong attention to detail and accuracy.
- Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization.
- Understanding of Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines.
- Applicable knowledge of the drug development process.
- Proficiency working in MS Windows environment and with Windows-based desktop productivity applications (MS Office) including Adobe Acrobat technology is required.
- At least a bachelor’s degree in regulatory affairs, the sciences, or related areas of study, and relevant experience
- Experience in the pharmaceutical industry with at least 5 years of regulatory operations experience or equivalent. High degree of knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers is required.
- Past experience in regulatory submission planning is required.
- Working knowledge of drug laws, regulations and guidelines is essential.
- Ability to work across cultures
Requirements of the job:
- this position may require some domestic and international travel
- this position will suit an individual who is able to operate with discretion and confidentiality about sensitive data
- this position requires success collaboration on cross-functional teams and interactions with external partners
- Head of Global Regulatory Operations
- Head of Submission Management
- Head of GBU Submission Management
- Regulatory Dossier Lead
- Head of GBU Submission Management
- Head of Submission Management
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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