Regulatory Consultant (CMC-EU, GCC & AU)
J
JobgetherLife Sciences
Based in IndiaFull-Time
Salary not disclosed
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Job Details
- Required Skills
- Project Management
Requirements
- Proven experience in regulatory affairs, particularly in Chemistry, Manufacturing, and Controls (CMC) regulatory activities across global markets.
- Strong understanding of regulatory submission processes, product registrations, lifecycle management, and health authority interactions.
- Experience supporting regulatory activities within European Union, GCC, and Australian markets is highly desirable.
- Ability to analyze regulatory requirements, identify gaps, and develop practical strategies for successful submissions.
- Experience working with multidisciplinary teams in pharmaceutical, biotechnology, or life sciences environments.
- Strong knowledge of global regulatory guidelines and compliance expectations.
- Excellent project management skills with the ability to manage multiple priorities, timelines, and stakeholders.
- Strong written and verbal communication skills, with the ability to prepare regulatory documents and present recommendations clearly.
- Strong attention to detail, analytical thinking, and commitment to quality standards.
Responsibilities
- Independently manage regulatory activities for both standard and complex submissions, ensuring alignment with global and regional regulatory requirements.
- Conduct regulatory research and gap analyses to support product development strategies, regulatory plans, and submission preparation.
- Prepare and contribute to administrative and technical components of regulatory submissions, including pre-approval applications, product registrations, lifecycle management activities, and post-approval updates.
- Support preparation of briefing documents, agency meeting materials, and regulatory interactions with health authorities.
- Manage daily regulatory project activities according to agreed timelines, scope, budgets, and strategic objectives.
- Provide regulatory expertise within multidisciplinary project teams, collaborating with clinical and technical specialists throughout the product lifecycle.
- Ensure compliance with applicable global regulations, internal procedures, quality standards, and regulatory best practices.
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