Global CMC Regulatory Manager

Job content

Are you passionate about making a meaningful impact on patients’lives through gene therapy? Do you have a strong background in regulatory affairs and CMC? If so, we want you on our team!

We are looking for a Global Regulatory Manager CMC to join our dynamic team of a leading biotech company in Bern, for an initial contract of 12 months, with possibility of extension.

Responsibilities:

• Operational Regulatory CMC Activities: You will be at the forefront of coordinating, preparing, and reviewing regulatory submission packages for our Gene Therapy portfolio. Your expertise will be crucial in crafting responses to Health Authorities.
• Submission Support: Be the driving force behind scheduling and prioritizing CMC-related submissions. Your organization and attention to detail will keep our regulatory activities on track.
• Documentation Maintenance: Take charge of compiling and maintaining CMC documentation/CTD for regulatory submissions. Collaborate with cross-functional teams to ensure our documentation meets the highest standards.
• Document Management: Ensure regulatory CMC documents/CTD documentation are formatted correctly and maintained within our document management system. Keep relevant lists and tracking documents up to date.
• Regulatory Assessments: Provide timely and compliant regulatory assessments and execute CMC changes efficiently. Your critical thinking and problem-solving skills will be invaluable.
• Compliance and Gap Analysis: Evaluate technical and scientific CMC information for compliance with regulatory requirements. Conduct gap analyses and propose solutions to mitigate risks.

Qualifications:

• Bachelor’s or advanced degree in a relevant scientific field.
• Several years of experience in regulatory affairs with a focus on CMC.
• Knowledge of biotech and regulatory requirements.
• Fluent english
• Detail-oriented and able to work effectively in cross-functional teams.

Our client require candidates to hold an EU passport or ID or a valid Swiss Permit. No sponsorship offered.

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