Regulatory Affairs CMC Expert in Development - Small Molecules (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Reg Affairs & Safety Pharmacovigilance

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We are expanding our product and project pipeline in Novo Nordisk and are looking for an engaged RA CMC Expert with expertise in small molecules to join RA CMC Emerging Technologies (ET) in Novo Nordisk Global Regulatory Affairs unit. If you are curious about drug development, willing to take lead, set strategic direction in projects and be a regulatory affairs expert in a growing organization- then this might be the job you are looking for.

The position
As a Regulatory CMC Expert, you will lead activities for a small molecule project in late-development and registration. You will have the opportunity to drive scientific and regulatory discussion across our portfolio.

In this role, you will work closely together with decision-makers across multiple functions in a global environment. You will build partnerships with key Stakeholders from other functions internally as well as external partners. You will also provide strategic, tactical, and operational regulatory input to projects.

In addition, you will also be responsible for and contribute to the success of RA CMC ET by:

• Applying regulatory intelligence and establishing strategy for submission of Clinical trial applications and Marketing authorisation
• Driving submission of regulatory files, response to questions from health authorities
• Ensuring compilation, review and submission of pre-meeting packages for authority meetings; conducting rehearsals and participate in meetings
• Addressing dilemmas and analyse complex challenges to propose new ways to support projects with regulatory expertise
• Facilitating the regulatory approval process by identifying key risks and ensure timely, complete and high-quality answers to authority questions
• Contributing to improvement projects

Our commitment to innovation also applies to the way we work: We embrace the hybrid workplace where you have the opportunity to blend working from home and the office. The position is based in Søborg, and relocation to Denmark is required for candidates from abroad. We offer relocation assistance for the selected candidate.

Qualifications
You hold a Master and/or Ph.D. degree in life sciences. You have acquired solid Regulatory CMC experience either from the pharmaceutical industry or from a health authority.

We imagine that you have minimum 4-8 years of experience with above and have hands-on experience with small molecules and/or synthetics and within several of the areas below:

• In-depth knowledge of regulatory CMC requirements for CTA’s and/or NDA’s/BLA’s
• Extensive global regulatory CMC experience in obtaining product licenses in the EU, US and other major countries
• Extensive experience working with small molecules preferred
• Broad understanding of global drug development
• Experience of interacting with key regulatory authorities e.g. FDA, EMA, PMDA, and scientific advisory meetings
• Experience of 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. 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 also thrive with the challenging reality of international communication across time zones, cultures, and circumstances.

About the department
RA CMC Emerging Technologies is a newly established area comprised of 25 colleagues in two teams, working in projects from the early phases of drug development and life cycle of the marketed products worldwide. We are responsible for driving the regulatory affairs CMC strategies and submission activities related to the drug projects based on emerging technologies, e.g. siRNA as well as the increasing small molecule and oral development pipeline in Novo Nordisk.

We strive to be the best in the industry, delivering safe and innovative products to the patients by strategic business partnering, proactive collaboration with health authorities and efficient operations.

Our organisation is dynamic and there is focus on improving work processes both in relation to implementation of new regulations and thinking “out of the box”, setting bold regulatory strategies enabling us to go above and beyond to the benefit of the business and the patients we serve.

Our work is essential to keep bringing innovative, patient-centric, and best-in-class solutions to our patients. That calls for team spirit, collaborative minds, skilled colleagues, and a great focus on knowledge-sharing. So, look forward to being surrounded by talented, cooperative, and embracing teammates in a strong and empowering culture.

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, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

Visit our Regulatory Affairs Careers webpages
For more information about job content and qualifications, please visit the Novo Nordisk Regulatory Affairs Careers webpages at https://www.novonordisk.com/careers/career-areas/research-and-development/regulatory-affairs-careers.html

Contact
For more information, please contact Ana Mora Agudo +45 3075 0292.

Deadline for application
30th June 2024

Candidates will be evaluated on an ongoing basis, so do apply at the earliest.

Please submit an English version of your resume and include a few sentences about your motivation towards this position.

To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

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.