Global Regulatory Submission Manager Regulatory Affairs

Why This Role Matters
The Global Regulatory Submission Manager plays a critical role in ensuring that pharmaceutical products meet international regulatory requirements and documentation standards. The position supports global drug development and product registration by managing regulatory submissions, maintaining documentation systems, and ensuring compliance with global health authority guidelines.

Job Description
The Global Regulatory Submission Manager will oversee regulatory documentation processes, coordinate global submission activities, and support regulatory strategy development for pharmaceutical products. The role involves managing regulatory dossiers, maintaining documentation systems, and collaborating with cross-functional teams to ensure successful regulatory approvals and lifecycle management.

Key Features of the Role
• Opportunity to work on global regulatory submission projects
• Exposure to international regulatory guidelines including FDA, ICH, and EMA
• Involvement in regulatory strategy and dossier management
• Collaboration with global cross-functional teams
• Professional growth in pharmaceutical regulatory affairs and global submissions

Responsibilities
• Manage multiple global regulatory submission projects and coordinate documentation activities
• Develop submission strategies and provide regulatory intelligence for product development and registration
• Maintain controlled documentation systems and ensure proper record retention processes
• Coordinate the preparation and assembly of regulatory dossiers for global submissions
• Ensure compliance with regulatory agency requirements and documentation standards
• Maintain documentation change control systems for technical and non-technical records
• Analyze regulatory data and prepare summaries, reports, and documentation abstracts
• Collaborate with internal teams and external stakeholders to support regulatory submissions
• Contribute to the implementation of global regulatory systems, tools, and processes
• Support reporting of technical complaints, adverse events, or product-related scenarios when required

Required Qualifications

Educational Requirements:
• Bachelor’s Degree in Life Sciences or a related discipline
• Master’s Degree preferred

Experience and Skills:
• Minimum 5 years of professional experience in the pharmaceutical or life sciences industry
• 3–5 years of experience in regulatory affairs or regulatory submission management
• Knowledge of global regulatory submission formats and publishing processes
• Understanding of the drug development process and regulatory lifecycle
• Familiarity with global health authority guidelines such as FDA, ICH, and EMA
• Strong project management and organizational skills
• Excellent written, verbal, and presentation skills
• Proficiency in MS Office and regulatory documentation systems
• Strong analytical and problem-solving abilities
• Ability to work independently and collaborate with cross-functional teams

Salary Insights:
• Salary details were not specified in the job posting

Company Overview
Novartis is a global healthcare company focused on developing innovative medicines to address serious diseases. The company works across pharmaceuticals, biotechnology, and advanced therapies to improve patient outcomes worldwide through science-driven healthcare solutions.

FAQs
• What qualification is required for this role?
Candidates should have a Bachelor’s degree in Life Sciences or a related discipline. A Master’s degree is preferred.

• How much experience is required?
Applicants should have at least 5 years of professional experience with 3–5 years in regulatory affairs or regulatory submission roles.

• What regulatory guidelines are relevant for this role?
The role involves working with global regulatory standards such as FDA regulations, ICH guidelines, and EMA directives.

• What type of work will the candidate perform?
The role focuses on managing global regulatory submissions, maintaining documentation systems, coordinating dossiers, and supporting regulatory strategy development.

Application Tips
• Highlight experience with global regulatory submissions and dossier preparation
• Mention knowledge of international regulatory guidelines such as FDA, ICH, and EMA
• Showcase project management experience in regulatory affairs
• Emphasize skills in documentation management and regulatory compliance
• Include experience working with cross-functional global teams in pharmaceutical projects