We are seeking a Regulatory CMC Manager to join us at Vaccibody

Our Vaccibody Team is expanding, and we are now looking for a Regulatory CMC Manager to join us! 

The role will strengthen the regulatory involvement in the CMC activities across all Vaccibody projects by providing operational and strategic regulatory input with an emphasis on CMC matters. You will manage and lead regulatory CMC and device activities and provide strategic and operational input to support worldwide product development. Moreover, you will ensure high quality CMC documentation in regulatory submissions such as clinical trial applications, IND submissions, meeting briefing packages, and effectively manage associated timelines.

Job responsibilities

The responsibilities of the position include but are not limited to:

• Developing and executing sound and robust global clinical stage regulatory CMC strategies for Vaccibody’s products
• Writing and coordinating CMC documentation for regulatory meetings and submissions in close collaboration with relevant functional area representatives and the regulatory team
• Driving Agency interactions on CMC and device issues
• Assisting relevant functions / members of the project teams in ensuring timely follow-up on Health Authority requests and commitments
• Ensuring compliance with EU, US and selected RoW regulatory CMC requirements
• Ensuring alignment of CMC documents and coordinating regulatory principles across development projects
• Staying up-to-date with and communicate relevant regulatory guidances and regulations and provide training internally
• Ensuring that relevant SOPs are in compliance with regulatory requirements and standards

Education and experience requirements

• MSc/PhD, in pharmaceutical science or from related field
• At least 5 years of experience from working with regulatory CMC documentation in drug development (device development is an advantage)
• Experience from the US and EU regulatory CMC environment, including Agency interactions
• Preferably experienced with ATMP or biological product development
• Excellent English skills, both verbally and in writing
• Skilled in using different IT systems

Who are we looking for?

When hiring new employees, we also look for the individuals who are inspired by Vaccibody’s entrepreneurial spirit and whom we think would be a good fit with our collaborative and inclusive company culture. We believe that you are driven by an eagerness to continuously grow, you are proactive and not afraid of facing new challenges. Your strong interpersonal skills enables you to both motivate and effectively communicate with other development staff in a fast-paced working environment. You believe that we get things done through team work and a "we" mentality. You take responsibility and can work independendly whilst being flexible and enjoy managing multiple tasks at the same time.

Location

Positioned either in Oslo/Denmark

Deadline: 26.03.2021

Applications will be reviewed after the deadline. We do not accept applications by mail.