Senior RA CMC Manager

Senior RA CMC Manager

Bavarian Nordic

Do you want to influence Bavarian Nordic’s product development towards regulatory approvals? Then this might be the job for you!

Improving and saving lives through innovative vaccines

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of life-saving vaccines.  Currently Bavarian Nordic has two very interesting phase 3 programs lined up for submission and are therefore looking for a Senior RA CMC Manager to support and influence their product development towards regulatory approvals.

Set your mark on Bavarian Nordic’s upcoming new vaccine approvals

As Senior RA CMC Manager, you will be responsible for defining the regulatory path for new drug developments together with the rest of the regulatory organisation, and you will deliver regulatory expertise to enable fit for purpose and fast paced CMC development programs.

Using your scientific and regulatory skills, you will advise the manufacturing and development organisations to develop the most optimal CMC development strategy that will support the defined regulatory path. You will be working with four RA CMC colleagues who also work with the development portfolio.

As you will partake in several Scientific Advice meetings, you will as Senior RA CMC Manager be joining Bavarian Nordic in a very interesting time, where you will be able to truly set your mark on Bavarian Nordic’s upcoming new vaccine approvals.

Join an ambitious Regulatory Affairs CMC team

The Regulatory Affairs CMC team consist of eight employees and two CMC Contractors, and you will report to the Senior Director RA CMC. The Regulatory Affairs CMC team is responsible for regulatory matters related to both new drug developments and life cycle management of registered products. The team is responsible for writing the quality sections for IND/CTA and BLA/MAA applications and for answering technical requests from Health Authorities. RA CMC is part of the global Regulatory Affairs team.

Experienced in RA CMC with strong interpersonal skills

Your hold a university degree within a scientific discipline, preferably M. Sc. in Chemistry or Pharmacy, Ph.D. or similar. You have 8-10 years of experience from a regulatory agency or the pharmaceutical or biotech industry. You have experience working within RA CMC from a global perspective, and experience liaising with Regulatory Agencies. Moreover, experience with vaccine approvals is an advantage.

To succeed in this role, you must be able to take responsibility and guide and support your colleagues through the RA landscape. You have a proven ability to build relationships and you work effectively on interdisciplinary and cross functional teams. Furthermore, you have a strong attention to details and manage working independently while being responsible and accountable. Good planning skills is an advantage.

As a person you are a team worker, dedicated, take pride in what you do, and you have an agile and bold mindset.  Fluency in English both written and spoken is a requirement.

Bavarian Nordic offers

Bavarian Nordic believes in the power of the team, and you will be part of a global organisation of more than 920 dedicated people with diverse backgrounds and viewpoints who are bound together by their commitment to protect lives every day. Bavarian Nordic believes in creating an inclusive and flexible workplace with a strong focus on personal and professional development, because they need each other to take things further. Bavarian Nordic operates in a world in constant flux and always explore new opportunities. So, if you are open-minded and have the willpower to succeed, you might just be a perfect fit!

Would you like to know more?

The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group. If you want to learn more about this position before submitting your application, please do not hesitate to contact Research Consultant, Signe Bülow Hansen on email: signe.hansen@compasshrg.com. Please submit your application and CV as soon as possible, if you are interested. Applications will be processed on an ongoing basis. Please note that all enquiries will be handled with confidentiality and that we will reply to the email address from which you send your CV.

Deadline forapplication:As soon as possible
Workplace: Greater Copenhagen
Reference: 2205.457
Company: Bavarian Nordic