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Title
Text copied to clipboard!Chemistry, Manufacturing and Controls Officer
Description
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We are looking for a CMC Officer to join our regulatory affairs or pharmaceutical development team. The CMC Officer plays a critical role in ensuring that all Chemistry, Manufacturing, and Controls (CMC) documentation complies with regulatory requirements and supports the successful development, registration, and lifecycle management of pharmaceutical products. This position requires a deep understanding of pharmaceutical manufacturing processes, quality control, and regulatory guidelines such as ICH, FDA, and EMA standards.
The CMC Officer will be responsible for preparing, reviewing, and maintaining CMC sections of regulatory submissions including INDs, NDAs, MAAs, and variations. The role involves close collaboration with cross-functional teams including R&D, Quality Assurance, Manufacturing, and Regulatory Affairs to ensure timely and accurate documentation. The ideal candidate will have strong project management skills, attention to detail, and the ability to interpret complex scientific data.
In addition to document preparation, the CMC Officer will monitor changes in regulatory requirements and ensure that internal processes and documentation remain compliant. They will also support audits and inspections by providing relevant CMC documentation and responding to regulatory queries. This role is essential for ensuring that pharmaceutical products are developed and manufactured in accordance with global regulatory standards, ultimately contributing to patient safety and product efficacy.
This is an excellent opportunity for professionals with a background in pharmaceutical sciences, chemistry, or a related field who are looking to make a significant impact in the regulatory landscape of drug development.
Responsibilities
Text copied to clipboard!- Prepare and review CMC sections of regulatory submissions
- Ensure compliance with global regulatory guidelines (ICH, FDA, EMA)
- Collaborate with cross-functional teams to gather technical data
- Maintain up-to-date knowledge of regulatory requirements
- Support audits and inspections with relevant documentation
- Manage lifecycle updates for approved products
- Track and implement changes in manufacturing processes
- Ensure timely submission of CMC documentation
- Review and approve technical reports and specifications
- Participate in regulatory strategy meetings
Requirements
Text copied to clipboard!- Bachelor’s or Master’s degree in Pharmacy, Chemistry, or related field
- 3+ years of experience in CMC regulatory affairs or pharmaceutical development
- Strong knowledge of ICH, FDA, and EMA guidelines
- Excellent written and verbal communication skills
- Attention to detail and strong organizational skills
- Ability to interpret complex scientific data
- Experience with regulatory submission platforms
- Project management experience is a plus
- Ability to work independently and in a team
- Proficiency in Microsoft Office and document management systems
Potential interview questions
Text copied to clipboard!- Do you have experience with CMC regulatory submissions?
- Which regulatory agencies have you worked with (e.g., FDA, EMA)?
- Can you describe your experience with pharmaceutical manufacturing processes?
- How do you stay updated on regulatory changes?
- Have you participated in regulatory audits or inspections?
- What document management systems are you familiar with?
- How do you ensure accuracy in technical documentation?
- Describe a challenging CMC issue you resolved.
- What is your experience with cross-functional collaboration?
- Are you familiar with lifecycle management of pharmaceutical products?
