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Title
Text copied to clipboard!CMC Senior Officer
Description
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We are looking for a highly experienced and detail-oriented CMC Senior Officer to join our dynamic regulatory affairs team. The successful candidate will play a critical role in managing Chemistry, Manufacturing, and Controls (CMC) regulatory activities, ensuring compliance with global regulatory requirements and standards. This position requires a deep understanding of pharmaceutical manufacturing processes, regulatory submissions, and quality assurance practices.
The CMC Senior Officer will be responsible for preparing, reviewing, and submitting regulatory documentation related to drug substance and drug product manufacturing processes. They will collaborate closely with cross-functional teams, including manufacturing, quality assurance, quality control, and research and development, to ensure timely and accurate submissions. The role involves maintaining up-to-date knowledge of regulatory guidelines and industry best practices, providing strategic regulatory guidance to internal stakeholders, and ensuring that all CMC documentation meets regulatory expectations.
In addition, the CMC Senior Officer will be responsible for managing interactions with regulatory authorities, responding to queries, and addressing any issues or deficiencies identified during regulatory reviews. They will also participate in regulatory inspections and audits, providing expert support and guidance to ensure successful outcomes.
The ideal candidate will have extensive experience in regulatory affairs, specifically in the area of CMC, and possess strong analytical, organizational, and communication skills. They must be capable of working independently, managing multiple projects simultaneously, and meeting tight deadlines. A proactive approach to problem-solving, attention to detail, and the ability to interpret complex regulatory requirements are essential for success in this role.
The CMC Senior Officer will also be expected to contribute to continuous improvement initiatives within the regulatory affairs department, identifying opportunities to streamline processes, enhance efficiency, and improve overall regulatory compliance. They will provide training and mentorship to junior regulatory staff, fostering professional growth and development within the team.
This role offers an exciting opportunity to work in a challenging and rewarding environment, contributing to the successful development and commercialization of pharmaceutical products. The successful candidate will have the chance to collaborate with industry experts, gain exposure to diverse regulatory environments, and play a key role in ensuring patient safety and product quality.
If you are passionate about regulatory affairs, possess extensive CMC experience, and are looking for a role where you can make a significant impact, we encourage you to apply. Join our team and help us continue to deliver high-quality pharmaceutical products to patients worldwide.
Responsibilities
Text copied to clipboard!- Prepare, review, and submit CMC regulatory documentation for drug substances and products.
- Collaborate with cross-functional teams to ensure timely and accurate regulatory submissions.
- Maintain current knowledge of global regulatory guidelines and industry best practices.
- Manage interactions with regulatory authorities, responding to queries and addressing deficiencies.
- Participate in regulatory inspections and audits, providing expert support and guidance.
- Provide strategic regulatory guidance to internal stakeholders regarding CMC requirements.
- Contribute to continuous improvement initiatives within the regulatory affairs department.
- Mentor and train junior regulatory staff, fostering professional growth and development.
Requirements
Text copied to clipboard!- Bachelor's degree in Pharmacy, Chemistry, Biology, or related scientific discipline; advanced degree preferred.
- Minimum of 5 years of experience in regulatory affairs, specifically in CMC.
- In-depth knowledge of global regulatory requirements and guidelines related to pharmaceutical manufacturing.
- Strong analytical, organizational, and communication skills.
- Ability to manage multiple projects simultaneously and meet tight deadlines.
- Experience interacting with regulatory authorities and managing regulatory inspections.
- Proactive problem-solving skills and attention to detail.
- Proficiency in regulatory submission software and document management systems.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with preparing and submitting CMC regulatory documentation?
- How do you stay updated on changes in global regulatory guidelines related to CMC?
- Describe a situation where you successfully managed interactions with regulatory authorities.
- What strategies do you use to manage multiple regulatory projects simultaneously?
- Can you provide an example of how you contributed to process improvement within a regulatory affairs team?
