Global Submission Lead
Sanofi
19 days ago
Remote friendly (Cambridge, MA)
United States
$122,250 - $176,583.33 USD yearly
Operations
Main Responsibilities
Submission Management Activities
- Lead planning and delivery of worldwide regulatory submissions to support development and registration of new global products.
- Develop global submission filing plans and participate in Global Regulatory Product Teams (GRA BluePrint model).
- Provide subject matter expertise on ICH, eCTD, and electronic submission requirements and related regulatory submission format guidelines.
- Create and maintain submission plans using publishing tools and processes.
- Lead project teams to control submission component receipt and workflow completion.
- Identify issues early and contribute to resolution before filing dates are impacted.
- Ensure high-quality, timely submissions to global health authorities aligned with Sanofi and authority standards.
- Stay current on global regulatory guidelines, approval processes, procedures, and submission templates.
- Serve as SME for dossier types/processes and train/mentor GRO peers.
- Oversee and manage vendors supporting regulatory submission goals.
Submission Partnerships
- Act as a key contact for leadership on partnerships with external co-developer pharmaceutical companies to implement e-Submission strategies.
- Ensure adherence to internal standards (SOPs, guidance documents, policies) throughout application lifecycle.
- Coordinate with external regulatory operations to develop milestones/timelines and support business continuity.
Drive Operational Effectiveness
- Implement standards and process efficiencies for submission publishing and support change-management communications.
- Assist with writing/reviewing process documentation (SOPs/policies) as needed.
- Oversee continuous improvement of GRO systems and procedures.
- Lead and/or represent GRO in GRA special initiatives.
About You
Qualifications & Experience
- Bachelor’s degree (or equivalent) in regulatory affairs, life sciences, or related field.
- 5+ years in pharma (regulatory operations or equivalent), including strong knowledge of dossier assembly/production and regulatory dossier structure, standards, and requirements.
- Understanding of global regulatory regulations/guidelines (FDA/EU) and ICH; strong knowledge of global submission processes.
- Working knowledge of drug laws, regulations, and guidelines.
Technical & Soft Skills
- Cross-cultural collaboration.
- Past experience in regulatory submission planning (preferred).
- Knowledge of drug development process (plus).
- Proficiency in MS Windows, MS Office, and Adobe Acrobat; knowledge of Veeva Vault (plus).
- Self-starter with strong leadership, tact/diplomacy, and a flexible, positive approach.
- Ability to lead projects/timelines in a matrix environment.
- Strong attention to detail.
- Excellent verbal/written communication across organizational levels.
Additional Requirements
- Some domestic and international travel may be required.
- Operate with discretion and confidentiality about sensitive data.
- Collaborate successfully with cross-functional teams and external partners.
Submission Management Activities
- Lead planning and delivery of worldwide regulatory submissions to support development and registration of new global products.
- Develop global submission filing plans and participate in Global Regulatory Product Teams (GRA BluePrint model).
- Provide subject matter expertise on ICH, eCTD, and electronic submission requirements and related regulatory submission format guidelines.
- Create and maintain submission plans using publishing tools and processes.
- Lead project teams to control submission component receipt and workflow completion.
- Identify issues early and contribute to resolution before filing dates are impacted.
- Ensure high-quality, timely submissions to global health authorities aligned with Sanofi and authority standards.
- Stay current on global regulatory guidelines, approval processes, procedures, and submission templates.
- Serve as SME for dossier types/processes and train/mentor GRO peers.
- Oversee and manage vendors supporting regulatory submission goals.
Submission Partnerships
- Act as a key contact for leadership on partnerships with external co-developer pharmaceutical companies to implement e-Submission strategies.
- Ensure adherence to internal standards (SOPs, guidance documents, policies) throughout application lifecycle.
- Coordinate with external regulatory operations to develop milestones/timelines and support business continuity.
Drive Operational Effectiveness
- Implement standards and process efficiencies for submission publishing and support change-management communications.
- Assist with writing/reviewing process documentation (SOPs/policies) as needed.
- Oversee continuous improvement of GRO systems and procedures.
- Lead and/or represent GRO in GRA special initiatives.
About You
Qualifications & Experience
- Bachelor’s degree (or equivalent) in regulatory affairs, life sciences, or related field.
- 5+ years in pharma (regulatory operations or equivalent), including strong knowledge of dossier assembly/production and regulatory dossier structure, standards, and requirements.
- Understanding of global regulatory regulations/guidelines (FDA/EU) and ICH; strong knowledge of global submission processes.
- Working knowledge of drug laws, regulations, and guidelines.
Technical & Soft Skills
- Cross-cultural collaboration.
- Past experience in regulatory submission planning (preferred).
- Knowledge of drug development process (plus).
- Proficiency in MS Windows, MS Office, and Adobe Acrobat; knowledge of Veeva Vault (plus).
- Self-starter with strong leadership, tact/diplomacy, and a flexible, positive approach.
- Ability to lead projects/timelines in a matrix environment.
- Strong attention to detail.
- Excellent verbal/written communication across organizational levels.
Additional Requirements
- Some domestic and international travel may be required.
- Operate with discretion and confidentiality about sensitive data.
- Collaborate successfully with cross-functional teams and external partners.