Lonza
Manager, Regulatory Affairs CMC
Project is closed
Posted
Feb 5, 2025
Job ID:
R65460
Location
Bend, OR
Hours/week
40 hrs/week
Payrate range
Unknown
Key Responsibilities:
- Provide regulatory & strategic mentorship (Regulatory Plans) to internal and external customers for our Drug Product business in Bend (US).
- Collaborate with team, customers, and collaborators to ensure CMC submissions meet regulatory standards.
- Proactively coordinate the regulatory CMC aspects of programs, providing mentorship and authoring Dossiers. Ensure the submission of CMC documentation supporting clinical trial applications and marketing submissions is in alignment with the development phase.
- Review and evaluate the regulatory impact of the change requests for Drug Products manufacturing processes, including technology transfer.
- Submit country-specific health authority supporting documents such as Drug Master Files (DMFs), Site Master Files (SMF), or other records on behalf of customers.
- Apply previous experience in Quality Control, Analytical Development, manufacturing process, Quality Assurance, or Program Management to suggest alternative solutions to challenges from internal and external customers.
- Apply a solution and service-minded proactive approach even with challenging customers.
- Support the US Regulatory Affairs Drug Product Lead in Tampa.
- Perform other duties as required.
- Degree in chemistry, biology, biochemistry, pharmacy, or equivalent experience.
- Extensive experience in the pharmaceutical and biotechnology industries, specializing in small and midsize molecules, with additional understanding of large molecules being advantageous.
- Exceptional communication and outstanding writing skills, proficiency in English (additional languages are advantageous).
- Proactive, problem-solving attitude, with a strong dedication to regulatory excellence and a passion for driving healthcare innovation.
- Independent, self-motivated, organized, able to multi-task, skilled in communication with the capability to excel in a dynamic, cross-functional matrix environment.
- Great teammate who is prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
- Successful candidates must be able to learn quickly and work independently in a fast-paced environment.
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