CMC Regulatory Affairs 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 health & quality of life
Bavarian Nordic develops innovative and safe vaccines to treat and prevent cancer and infectious diseases. Their aim is to improve health and quality of life for children and adults around the world.

Become part of an experienced and dedicated team
You will be a part of an ambitious Regulatory Affairs CMC team consisting of seven employees and report to the Senior Director. The Regulatory Affairs CMC team is responsible for regulatory matters related to both new drug developments and life cycle management of registered products. They are responsible for writing the quality sections for IND/CTA and BLA/MA applications and for answering technical requests from the Health Authorities (e.g. FDA, EMA, Health Canada).

Leading and coordinating RA programs for new facility
As CMC Regulatory Affairs Manager, you will be responsible for defining the regulatory path for new drug developments together with the rest of the regulatory organisation. You will work on new drug developments and maintenance of the INDs/IMPDs. Your scientific and regulatory skills will be used to advice 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 two colleagues who also work with the development portfolio.
You will lead the CMC regulatory submission strategy, identify submission risks and opportunities, lead regulatory applications and manage procedures through approval. You provide regulatory expertise and guidance on procedural and documentation requirements to cross-functional teams and across regulatory regions to ensure the delivery of business objectives. Your main tasks are:

  • Drive regulatory projects in a very agile organisation
  • Provide CMC regulatory advice to subject matter experts (Global Operations, Quality and R&D) based on current regulatory guidance
  • Develop timelines for CMC parts of the dossier and follow up with subject matter experts (Global Operations, Quality, R&D) to ensure timely and quality submissions
  • Develop and/or review regulatory documents to ensure that all submissions are of high quality
  • Provide strategic input and regulatory advice to the project teams on development programs
  • Review and provide regulatory assessment to proposed CMC changes
  • Lead the preparation of responses to CMC questions from Regulatory Authorities
  • Support/lead the preparation and conduct of Agency meetings, including preparation and coordination of briefing packages
  • Maintain knowledge of current global rules, regulations, and guidance governing development of drugs and biologics in all phases of development
  • Support the Senior Director in developing the regulatory management system

Experienced in CMC RA and strong interpersonal skills
You hold a university degree within a scientific discipline, preferably M. Sc. in Chemistry or Pharmacy, Ph.D. or similar. You have solid experience from a regulatory agency or the pharmaceutical or biotech industry working within CMC regulatory affairs from a global perspective. You have liaised with Regulatory Agencies and have excellent stakeholder management skills. If you have experience from a role in Manufacturing, Quality Control or Quality Assurance at some point in your career, it is an advantage. Furthermore, you communicate fluently in English both written and verbal.

You 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. As a person you are a team worker, dedicated, take pride in what you do, and you have an agile and bold mindset.

Bavarian Nordic offers
An exciting position in an international company with unique technology and a dedicated team. The company offer a dynamic work environment and an opportunity to develop both your personal and academic competencies.

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 Senior Research Consultant, Pernille Hemmingsen on email: pernille.hemmingsen@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 for application: As soon as possible
Workplace: Kvistgård
Company: Bavarian Nordic
Reference: 2005.330

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