Global Submission Lead

Main Responsibilities
Submission Management Activities
- Lead planning and delivery of worldwide regulatory submissions for new global products.
- Develop global submission filing plans and participate in Global Regulatory Product Teams (GRA BluePrint).
- Provide SME advice on ICH, eCTD, and electronic submission requirements and relevant regulatory guidelines.
- Create and maintain submission plans using publishing tools and processes.
- Lead project teams to ensure control of submission component receipt and workflow completion.
- Identify issues early and resolve before filing dates are impacted.
- Ensure high-quality, timely submissions aligned to Sanofi and Health Authority standards.
- Stay current on global regulatory guidelines, approval processes, and submission templates.
- Serve as SME for dossier types/processes; train and mentor GRO peers.
- Oversee and manage vendors supporting regulatory submissions goals.
Submission Partnerships
- Act as key contact for external co-developer partners to implement e-Submission strategies.
- Ensure adherence to internal standards (SOPs, Guidance Documents, Policies) across the application lifecycle.
- Coordinate milestones/timelines with Regulatory Operations external equivalent and support business continuity.
Drive Operational Effectiveness
- Implement standards and process efficiencies; support change-management communications.
- Assist with writing/reviewing process documentation (SOPs/Policies).
- Oversee continuous improvement and integrity of GRO systems/procedures.
- Lead/represent GRO in GRA special initiatives.

About You
- Bachelor’s degree (or equivalent) in regulatory affairs/life sciences/related.
- 5+ years in pharma regulatory operations (or equivalent), with strong dossier assembly/production and dossier standards/requirements knowledge.
- Understanding of global regulations (FDA/EU) and ICH; working knowledge of drug laws/regulations/guidelines.

Technical & Soft Skills (Required/Preferred)
- Ability to work across cultures.
- Preferred: experience in regulatory submission planning; knowledge of drug development process (plus).
- Required: MS Windows, MS Office, Adobe Acrobat; plus knowledge of Veeva Vault.
- Self-starter with strong leadership; ability to lead in matrix environments; strong attention to detail; excellent written/verbal communication.

Additional Requirements
- Some domestic/international travel; discretion/confidentiality with sensitive data; cross-functional collaboration.

Benefits (as stated)
- Health and wellbeing benefits and at least 14 weeks’ gender-neutral parental leave.