Regulatory Affairs CMC Specialists and Sr. Regulatory Affairs Professionals

Category:  Regulatory
Location: 

Søborg, Capital Region of Denmark, DK

   

We are expanding our product and project pipeline in Novo Nordisk and are looking for engaged RA CMC Specialists and Senior RA Professionals to join RA CMC (Chemistry, Manufacturing, and Controls) Biotech & Rare Disease in Novo Nordisk Global Regulatory Affairs unit. If you are curious about drug development within Rare and Other Serious Chronic Diseases, willing to take lead, set strategic direction in projects, and be a regulatory affairs expert in a growing organization this might be the job you are looking for.

 

About the department

Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring fast regulatory submissions and approvals in all our global markets. In RA CMC Biotech & Rare Disease we are a group of 40 highly skilled and dedicated regulatory professionals divided into three departments and involved in every Regulatory CMC aspect concerning our Rare and Other Serious Chronic Disease products. The project portfolio is rapidly growing; therefore, we are looking for several profiles to join us and work on projects within the SIRNA portfolio, small molecules, and protein-based biologics.

 

The position

As a Senior RA Professional and RA Specialist, you are expected to demonstrate leadership by setting strategic regulatory direction for high-impact projects in the Rare Disease space such as siRNA projects and other innovative investigational medicines. Your key responsibility is to ensure that scientific progress is turned into regulatory pathways. Working closely together with decision-makers across multiple functions in a global environment, you thrive with the challenging reality of international communication across time zones, cultures, and circumstances.

 

In addition, you will also be responsible for and contribute to the success of RA CMC BRD(Biotech & Rare Disease) by:

  • Providing strategic, tactical, and operational regulatory input to projects and guiding and mentoring junior colleagues
  • Identifying innovative regulatory approaches to novel development projects, including the design and implementation of regulatory strategies and plans
  • Addressing dilemmas and analysing complex challenges to propose new ways to support projects with regulatory expertise
  • Ensuring compilation, review, and submission of pre-meeting packages for authority meetings; conducting rehearsals and participating in meetings
  • Facilitating the regulatory approval process by identifying key risks and ensuring timely, complete, and high-quality answers to authority questions
  • Participating in cross-functional expert fora’s internal as well and external and contributing to improvement projects

 

The role requires the ability to work effectively with people from different functions and organisational levels, calling for high cultural awareness and the necessary skills to encourage and influence colleagues, governance, and key stakeholders. You will work in a fast-paced environment with an informal atmosphere and where good humour is always welcome. This is an opportunity for you to continue your individual development and stay updated within relevant regulatory and biotech disciplines and you can expect to build an extensive internal network.

 

Our commitment to innovation also applies to the way we work: We embrace remote work and the hybrid workplace. Whether you prefer to work from home, at the office, or to blend the two to your liking.

 

This position can either be connected to our headquarters in Søborg, Denmark – or for candidates currently based in the UK, in our offices in Gatwick, UK.

 

    Qualifications

You hold a Master’s and/or Ph.D. degree in life sciences. You have acquired advanced experience working with medicines SiRNA-based technologies, small molecules, and large biomolecules and have acquired solid Regulatory CMC experience either from the pharmaceutical industry or from a health authority.

 

We imagine that you have a minimum of 5-8 years of experience with the above and have hands-on experience within several of the areas below:

  • Broad understanding of global drug development
  • In-depth knowledge of regulatory requirements for CTA’s and/or NDA’s/BLA’s
  • Extensive global regulatory experience in obtaining product licenses in the EU, US, and other major countries
  • Experience in interacting with key regulatory authorities e.g. FDA, EMA, PMDA, and scientific advisory meetings
  • Experience in navigating within an environment of tight timelines, high complexity, non-standards, and diverse tasks in known and new therapy areas
  • Excellent analytical skills, systematic approach to identify root causes and propose innovative ways to solve problems
  • Ability to communicate complex scientific procedures with technical proficiency both orally and in writing. Advanced level written and spoken English is a prerequisite

 

As all work takes place in multidisciplinary project groups, we expect you to be a dedicated team player, find it easy to build working relationships, and gain recognition amongst stakeholders with your proactiveness, integrity, and communication skills.

 

Working at Novo Nordisk

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. 

 

Contact

For more information, please contact Philip Avnstrøm at +45 3077 7895 or Nicolai Frøslev Saabye at +45 3075 4135

 

Deadline for application                                               

9 Oct 2022

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.