Regulatory Submission Lead

About the role

You will lead planning, compilation and delivery of regulatory registration requirements for investigational and lifecycle activities globally. You will work closely with global submission teams, clinical, CMC, quality, publishing and local regulatory partners.

Responsibilities

• Plan, compile and deliver complete regulatory registration requirements for submission dossiers (electronic and paper) on agreed timelines.
• Cook up and track requirements and cross-functional inputs from clinical, CMC, quality and safety colleagues.
• Coordinate and manage Certificates of Pharmaceutical Product (CPPs), as well as notarization and legalization activities in support of global submissions.
• Maintain Regulatory information management system, submission trackers, version control and milestone plans to ensure transparency and audit readiness.
• Identify and implement process improvements, coach colleagues and share best practice.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, chemistry, regulatory affairs or related discipline, or equivalent experience.
• 3+ years of experience in regulatory affairs, submission management, publishing or lifecycle maintenance within the pharmaceutical or clinical research environment.
• Experience compiling regulatory dossiers and managing submission timelines for investigational or marketed activities.
• Experience interacting with Health Authorities, particularly the US FDA.

Preferred Qualifications

• Experience with regulatory content or information management systems such as Veeva Vault or similar platforms.
• Experience with Labeling, CMC content and Module 1 preparation for submissions.
• Experience with CPP processes and legalization/notarization requirements.
• Experience preparing electronic submissions and familiarity with eCTD principles or equivalent electronic submission practices.
• Experience preparing responses to authority questions and supporting regulatory meetings.
• Experience working in a global, matrix environment and coordinating third-party vendors or vendors, with the ability to interpret complex regulatory.
• Prior experience leading small project teams or serving as single point of contact for submissions.
• Professional certification in regulatory affairs, Notary or related field.
• Proven ability to manage third-party vendors and external partners.
• Strong written and verbal communication skills with the ability to present clear stakeholder updates.
• Strong organizational skills, attention to detail and proven ability to manage competing priorities under deadlines.
• Strong compliance mindset with high attention to detail.
• Good digital proficiency.