CMC Regulatory Affairs Manager

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

Contact:

Process Specialist – Serialisation

Do you have experience with serialisation? Do you thrive on working with complexities within serialisation? Then you might be the Process Specialist that Bavarian Nordic is looking for!

Join a transformative journey
Bavarian Nordic A/S is on an exciting growth journey and is therefore looking for a Process Specialist for Serialisation in a newly established position, as they are increasing their capacity by building a new state-of-the-art high speed Fill & Finish facility, next to the existing production facilities at their headquarters in Kvistgaard.

Bavarian Nordic A/S is a multinational biotech company and a leader in vector-based, active immunotherapy. Bavarian develops, manufactures and commercialises a portfolio of novel vaccines for the prevention and treatment of life-threatening, infectious diseases and cancer. Bavarian Nordic’s goal is to develop innovative and safe therapies against cancer and infectious diseases; to improve the health and quality of life for children and adults across the globe.

Bavarian Nordic A/S was founded in 1994 (IPO in 1998) and is headquartered in Kvistgaard, Denmark. Bavarian Nordic A/S is listed on Nasdaq Copenhagen and had their first product approved in 2013. Bavarian Nordic A/S employs +450 people in Denmark, Germany and the US. The headquarter facility in Kvisgaard houses a 9,000 m2 multiproduct manufacturing facility, various headquarter functions and the QA/QC departments.

Establishing the serialisation foundation for new commercial products
You will become part of a newly established team which plays a significant role in the implementation of the new large-scale Fill & Finish site including packaging. Preferably you have already played an active role in implementing and operationalizing seralisation in a commercial context. Knowledge about implementation including onboarding of CMOs, 3PLs etc. would be an advantage.

Interested
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, Kristian Aagerup on tel.: +45 70 20 12 75.

Please submit your application and CV, preferably as PDF files, as soon as possible. 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: Kvistgaard
Reference: 2005.024
Company: Bavarian Nordic A/S

Contact:

Senior Project Manager – Tech Transfer Lead

Develop the new and global commercial tech transfer for current and future vaccine programmes
Bavarian Nordic is on an exciting growth journey and is looking for a talented, highly motivated and experienced Senior Project Manager – Tech Transfer Lead to join them.

As Senior Project Manager – Tech Transfer Lead, you will get a unique opportunity to impact Bavarian Nordic’s future success by shaping and leading the new Tech Transfer of two highly successful vaccines in the transition phase from GSK to Bavarian Nordic.

Be Bavarian Nordic’s Tech Transfer expert and strategic lead in their new commercial journey
As Senior Project Manager – Tech Transfer Lead you will be an essential part of establishing the new integration management team (IMO team) with your knowledge and expertise in tech transfers, project management and strategic overview. You will be devoted to the most commercially complex tech transfer program in the history of Bavarian Nordic. The acquisition of the two vaccines from GSK has a total estimated cost of approximately six billion DKK. The Tech Transfer workstream will have a large number of stakeholders, which requires that the Senior Project Manager – Tech Transfer Lead can manage the complexity in such a large-scale project.

Some of the specific work tasks in the position are, but not limited to:

  • Scoping and leading, with end-to-end responsibility for the commercial Tech Transfer program, including project lead for several project managers.
  • Day-to-day execution of the workstream and cross workstream alignment to ensure delivery of overall program goals
  • Risk management and issue resolution
  • External and internal stakeholder management
  • Lead planning sessions and resolution workshops to gather requirements, devise recommendations, and accelerate integration decision-making

Talented, highly motivated and experienced Tech Transfer Lead
You hold a degree in life sciences, engineering, chemistry or equivalent with at least 7-10 years of complex Tech Transfer or CMC experience. You have worked with and led projects with 100+ stakeholders and have a strong strategic and business acumen. If you have experience with vaccines or other biologics at some point in your career, it is an advantage. Furthermore, you have demonstrated your ability to lead and facilitate collaborative teams, either as a people- or project manager.

As a person, you have a proactive mindset – you take the lead on overcoming challenges and show your team the way forward. You possess strong strategic and analytical abilities and you are comfortable both at the operational and strategic level. You believe in empowering people around you, offering them constructive feedback and guidance to improve their performance. Furthermore, you have excellent negotiation and communication skills.

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, Kristian Aagerup on tel.: +45 70 20 12 75. 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.

About Bavarian Nordic A/S
Bavarian Nordic consists of 450+ employees in Denmark, Germany and USA. In Kvistgaard Bavarian Nordic has their headquarters and large scale 9,000 sqm multiproduct manufacturing facility that consists of 300 employees. The company is on an exciting growth journey, which includes the construction of a new, state-of-the art manufacturing facility, strategic collaboration agreements with large pharmaceutical companies and government agencies, as well as a promising pipeline of vaccine candidates which progresses through the stages of development towards commercialisation.

Deadline for application: As soon as possible
Workplace: Kvistgaard
Reference: 2005.085
Company: Bavarian Nordic A/S

Contact:

IT Project Manager

Do you want to lead strategically significant IT projects in a fast-paced biotech company?
Bavarian Nordic is a multinational biotech company and a leader in vector-based, active immunotherapy.
We develop, manufacture, and commercialise a portfolio of novel vaccines for the prevention and treatment of life-threatening, infectious diseases and cancer; Our goal is to improve the health and quality of life for children and adults across the globe.
As our organisation is growing, we are experiencing an increase in strategic IT projects and we are therefore looking to strengthen our Project Office with an IT Project Manager.

Become part of a strategic Project Office with direct impact on strengthening our core business
The Project Office at Bavarian Nordic handles Project Portfolio Management, Project Governance and Project Execution across the value chain. We are a small but experienced team, who has a structured yet pragmatic approach in our way of working. It is important to us that we foster a positive and efficient project environment across departments and countries, so a desire to help us continuously improve how we work is something we expect from you.

In the role as IT Project Manager, you will report directly to the Senior Manager, Project Office and drive complex IT project from a-z; Everything from writing business cases, to training super-users after implementation. You will be an important sparring partner to top management, advising on the strategic direction of Bavarian Nordic’s future IT organisation, as well as secure buy-in from stakeholders across sites and functions.
Importantly, you will develop project plans, visualise clear objectives, deadlines and progress, as well as conduct regular project team and Steering group meetings. Continuously predicting and risk mitigating problems should therefore come naturally to you, as should meeting success criteria, deadlines and individual project budgets – in close cooperation with Finance.

Experienced IT Project Manager with a passion for GMP – and delivering outstanding projects
While it is not required that you come from a GMP set-up, we expect you to have well-versed Project Management toolbox, which you can apply to any type of project! You have experience with completing complex IT projects, are familiar with a variety of technical platforms/methodologies, and you are not afraid of implementing them in a regulated environment.
You thrive in a challenging working environment and are not concerned with changing priorities. You keep a clear focus on business strategy and are agile to adapt solutions accordingly – herein challenging colleagues and management on solutions, priorities etc. You are proactive and outgoing with an open mind and a great degree of creativity when finding/designing solutions. Structure and an organised approach to challenges are your nature. Ultimately, you recognise that excellent project management is a combination of people management and successful use of project methods and tools.

Agility, Dedication & Excellence
These three values are at the core of everything we do in our daily work!
Joining us at Bavarian Nordic means joining a company that offers a challenging, international work environment, where job satisfaction and personal growth have high priority. With the right mindset and motivation, you will have great opportunities to develop professionally and take on more responsibility. You will have great influence from day one, by playing a key role in ensuring a smooth and timely delivery of important projects, together with skilled and passionate colleagues.

If you also believe helping people is the best job in the world, we look forward to receiving your application!
Bavarian Nordic fosters an open culture, a definite ‘team-mindset’, where everyone is striving for excellence and believes in the same goal: Improving the health and quality of life for people with severe diseases across the globe, while at the same time allowing for individual impact and growth. At Bavarian Nordic, your ideas are heard, and your input is valued! You will be part of a team with a high level of expert skill and professionalism, and you will get to work with various stakeholders across the global organisation.

The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group A/S. If you want to learn more about this position before submitting your application, please do not hesitate to contact Anna Rasmussen on tel.: +45 70 20 12 75.
You can also apply via our website www.compasshrg.com and attach your CV, preferably as word file. Please note that we will reply to the email address from which you send your CV.

As a true multinational company, Bavarian Nordic A/S has collaboration agreements with the National Cancer Institute, Bristol-Myers Squibb, Janssen Pharmaceuticals Inc., the Biomedical Advanced Research and Development Authority, the US Department of Defense and PCI Biotech. The company has facilities in the United States, Holland, Canada, and operates internationally.
Bavarian Nordic offers a challenging, international working environment in which job satisfaction and personal development have a high priority. Bavarian Nordic encourages innovative thinking that promotes beneficial change for both the individual and the company. We are committed to making the company a great place to work by empowering our employees to perform their tasks to their own satisfaction, while simultaneously supporting the continuous development and success of the company.

Deadline for application: As soon as possible
Workplace: Kvistgård, Nordsjælland
Reference: 1905.454
Company: Bavarian Nordic

Contact: 

 

Senior Director of Regulatory Affairs CMC

Develop global CMC regulatory strategies for current and future vaccine programmes
Bavarian Nordic is a multinational biotech company that develops, manufactures, and commercialises a portfolio of novel vaccines for the prevention and treatment of life-threatening, infectious diseases and cancer, to improve the health and quality of life for children and adults across the globe. The company is on an exciting growth journey and is looking for a talented, highly motivated and experienced Regulatory Affairs professional to join them.

As Senior Director of Regulatory Affairs, you will get a unique opportunity to impact Bavarian Nordic’s future success by ensuring global CMC regulatory strategies, driving CMC activities and meetings with partners and international health authorities, as well as secure the successful commercialisation of several promising vaccines.

Take the lead on regulatory CMC activities and empower your team
You will be responsible for developing the global CMC regulatory strategy for current and future oncology and Infectious Diseases programmes, ensuring that regulatory documents are in compliance with health authority regulations and interact with international health authorities. Reporting to the Senior Vice President Quality, you will have regulatory accountability across all Bavarian Nordic’s vaccine development programmes and contribute actively in building regulatory capabilities. Based on your strong interpersonal skills and demonstrated track record of interacting with both domestic and foreign regulatory agencies, you maintain research competitiveness and advance development programmes through clinical application stages towards marketing authorisations for biologics.

You will lead a dedicated, international team of five Regulatory Affairs professionals placed in Kvistgård and Munich. Together with your team you plan, manage and execute regulatory activities, including submission and maintenance of EU, US and other international regulatory filings. As primary CMC regulatory representative, you lead and provide regulatory guidance to colleagues and partners and liaise with regulatory authorities, including overseeing the writing of pre-meeting briefing materials, leading the preparation for and facilitating sponsor interactions at regulatory meetings, and ensuring appropriate follow-up.

Some travelling is required (approx. 40 days/year).

Talented, highly motivated and experienced Regulatory Affairs Leader
You hold a degree in life sciences, chemistry or equivalent with at least 7-10 years of international, regulatory experience. You have solid working knowledge of drug development processes and knowledge of EU, HC and FDA regulatory requirements, including CMC submission experience and corresponding regulatory agency interactions. If you have experience with vaccines or other biologics at some point in your career, it is an advantage. Furthermore, you have demonstrated your ability to lead collaborative teams, either as a people- or project manager.

As a person, you have a proactive mindset – you take the lead on overcoming challenges and show your team the way forward. You demonstrate a sound business understanding when you develop regulatory strategies and you always consider the best solution for the whole company. You possess strong strategic and analytical abilities and you are comfortable both at the operational and strategic levels. You believe in empowering people around you, offering them constructive feedback and guidance to improve their performance. Furthermore, you have excellent negotiation and communication skills.

Excellence – Agility – Dedication!
Bavarian Nordic offers a challenging, international working environment, where job satisfaction and personal development have a high priority. Bavarian Nordic encourages innovative thinking that promotes beneficial change for both the individual and the company. Bavarian Nordic is committed to being a great place to work, by empowering its employees to perform their tasks to their own satisfaction, while aiming for the success of the company. With the right mindset and motivation, you will have great opportunities to develop professionally and take on more responsibility.

Would you like to know more?
Apply through Compass by uploading your CV in the application form and we will get in touch with you! If you have any questions call Senior Research Consultant, Pernille Hemmingsen or Partner, Rasmus Vendelbo Meyhoff +45 70 20 12 75. Candidates are assessed on a continuous basis, which is why we encourage you to send your CV as soon as possible.

About Bavarian Nordic A/S
Bavarian Nordic consists of 450+ employees in Denmark, Germany and USA. In Kvistgård Bavarian Nordic has their headquarters and large scale 9,000 sqm multiproduct manufacturing facility that consists of 300 employees. The company is on an exciting growth journey, which includes the construction of a new, state-of-the art manufacturing facility, strategic collaboration agreements with large pharmaceutical companies and government agencies, as well as a promising pipeline of vaccine candidates which progresses through the stages of development towards commercialisation.

Deadline for application: As soon as possible
Workplace: Kvistgård
Reference: 1905.185
Company: Bavarian Nordic A/S

Contact: