About the Role:
Join a global pharmaceutical organisation and play a key role within its Regulatory Science team. This position offers the opportunity to contribute to high-quality Chemistry, Manufacturing, and Controls (CMC) documentation that supports global regulatory submissions. If you have strong FDA CMC experience and enjoy working collaboratively in a cross-functional, international environment, this role provides both flexibility and meaningful impact.
Key Responsibilities:
CMC Authoring & Review: Author and review CMC sections for regulatory submissions, ensuring clarity, accuracy, and compliance with FDA and global regulatory requirements.
Regulatory Submissions: Prepare high-quality CMC documentation to support FDA and other global submissions, adhering to electronic submission standards.
CMC Systems & Data Management: Contribute to the maintenance and management of CMC data within Veeva RIM Vault (RIM Submissions).
Cross-Functional Collaboration: Work closely with Regulatory Science, Scientific and Regulatory Affairs, Quality Assurance, R&D, and Manufacturing teams to support submission activities.
Quality & Compliance: Ensure consistency, completeness, and regulatory compliance of all CMC documentation.
Regulatory Intelligence: Stay up to date with FDA regulations, guidance documents, and evolving regulatory expectations.
Issue Resolution: Identify, investigate, and resolve issues related to CMC documentation and submission processes.
Qualifications & Experience:
Experience: 3–5 years’ experience in FDA CMC writing and regulatory submissions, with hands-on use of Veeva RIM Vault (RIM Submissions).
Scientific Background: Degree in pharmaceutical sciences, chemistry, or a related scientific discipline.
Regulatory Knowledge: Strong understanding of FDA CMC regulatory requirements and guidelines.
Technical Skills: Proficient in document management systems and electronic submission standards.
Attention to Detail: Highly organised, with a strong eye for detail and document consistency.
Communication Skills: Excellent written and verbal communication skills, with the ability to convey complex technical information clearly.
Collaboration: Proven ability to work effectively within cross-functional, international teams.
Why Join Us?
This is an excellent opportunity to work remotely while contributing to high-impact regulatory activities within a multinational organisation. You’ll be part of a collaborative regulatory science function, supporting submissions that directly influence product development and global patient access.