Senior Submission Manager (Pharmaceutical, Remote)

Job summary

The Senior Submission Manager oversees global Clinical Trial Application (CTA) submissions, ensuring compliance and quality across the EU, UK, and other regions outside the US and Japan. This role requires strong regulatory expertise and the ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Manage submission processes for CTA applications in designated regions.
• Lead initial and lifecycle CTA submissions, coordinating with Rapid Response Teams and liaising with multidisciplinary teams and contract research organizations.
• Conduct quality control of submissions, reviewing documents and data in submission portals.
• Stay updated on regulatory requirements and industry standards.
• Represent Regulatory Operations on project teams, collaborating with various stakeholders to ensure timely submission deliverables.
• Work with functional areas to ensure compliance and readiness of documents.
• Identify regulatory risks and develop mitigation strategies.
• Ensure regulatory content is tracked and accessible in Document Management Systems.
• Adhere to submission timelines and health authority specifications.

Qualifications

• BA/BS degree or equivalent with 6–8 years of experience in the pharmaceutical industry, particularly in Regulatory Affairs submissions.
• In-depth knowledge of CTA requirements and global submission strategies.
• Strong understanding of health authority procedures across regions.
• Extensive experience with Electronic Document Management Systems (e.g., Veeva Vault).
• Proficient in MS Office Suite and Adobe Acrobat.
• Detail-oriented with the ability to deliver high-quality submissions under tight deadlines.
• Excellent communication and stakeholder management skills.
• Self-motivated with the ability to manage multiple priorities independently.

Skills

• Strong leadership and collaboration abilities.
• Innovative problem-solving skills.
• Ability to engage effectively across functions and seniority levels.

Education

• BA/BS degree or equivalent in a relevant field.

Tools

• Electronic Document Management Systems (e.g., Veeva Vault).
• MS Office Suite.
• Adobe Acrobat.