CMC Regulatory Affairs Senior Manager

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

CMC Regulatory Affairs Senior Manager will coordinate ​CMC Regulatory Affairs team and will report to the site Quality Head & QP.

Key responsibilities

• Regulatory Compliance: Ensuring that products meet all regulatory requirements for safety, efficacy, and quality. Proactively support clients in preparing and submitting documentation to regulatory agencies, such as the FDA, EMA, or other local authorities

• Liaison with Regulatory Bodies: Acting as a point of contact between the company and regulatory agencies. This involves communicating with these bodies to ensure that all regulatory requirements are understood and met.

• Regulatory Strategy: Developing and implementing regulatory strategies to ensure timely approval of facility and products. This includes staying up-to-date with changes in regulations and site authorization and advising the company on how to adapt to these changes. A hands-on approach to the development of regulatory strategy for new ATMP platforms development.

• Cross-functional Collaboration: Working closely with other departments, such as R&D, to ensure that all regulatory requirements are integrated into the product development process.

• Training and Guidance: Providing training and guidance to other employees on regulatory requirements and best practices.

• Risk Management: Identifying potential regulatory risks and developing strategies to mitigate these risks.

Your Credentials

• Educational Background:
  • A degree in life sciences, pharmacy, chemistry, or related field of study.

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• Experience and Knowledge:
  • Minimum 7-10 years' proven experience in a regulatory role, or in QP role (QP for ATMP would be an advantage) or in a related field within biotechnology, or similar industries.
  • Experience in advanced therapy medicinal products is an advantage.
  • Experience with regulatory submissions and interactions with regulatory agencies.
• Skills:
  • Attention to detail and the ability to manage multiple projects simultaneously.
  • Strong organizational and time management skills.
  • Ability to work independently as well as part of a team.
  • Ability to stay updated with changes in regulatory guidelines and industry trends.

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• Certifications (Optional):
  • QP certification (for ATMP would be an advantage).

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on