Regulatory Affairs CMC Scientific Director

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Søborg

Do you dream of a career with a global pharmaceutical company built on life-changing innovations? Do you want to drive the due diligence process, directly impact the projects with your scientific knowledge and set the regulatory direction? If it sounds interesting for you, then this is your chance to join us, as a Regulatory Affairs (RA), Chemistry, Manufacturing and Control (CMC) Scientific Director . Apply now! The position You will act as project lead for both due diligences and some very early projects and are expected to drive scientific and regulatory discussion across our portfolio of novel products such as siRNA projects and other innovative investigational medicines. This includes the assessment of the probability of regulatory success, risk analysis, and mitigation to ensure high quality scientific and regulatory recommendations and agreed conclusions on a timely basis across our portfolio of novel products such as siRNA projects and other innovative investigational medicines. Additionally, define best practices for conducting due diligence and support integration of acquisitions into our existing portfolio in RA CMC Biotech and Rare Disease (BRD). You are expected to demonstrate leadership by setting strategic regulatory direction for high impact projects in the Rare Disease and Other Serious Chronic Disease space. The key responsibilities to contribute to the success of RA CMC BRD are:
  • Guiding and mentoring junior colleagues
  • Providing strategic, tactical, and operational regulatory input to projects as well as contributing to and driving improvement projects
  • Identifying innovative regulatory approaches to novel development projects, including design and implementation of regulatory strategies and plans
  • Addressing dilemmas and analyse 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 participate in meetings
  • Facilitating the regulatory CMC due diligence and approval processes by identifying key risks and ensure timely, complete, and high-quality answers to authority questions
  • Participating in cross-functional expert fora’s internal as well and external
    • 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. Qualifications As an ideal candidate, you have:
  • A Master and/or Ph.D. degree in life sciences
  • Minimum of 10 years of experience with medicines such as ATMPs, siRNA based technologies, small molecules or large bio molecules and have acquired solid Regulatory CMC experience either from the pharmaceutical industry or from a health authority
  • Lead or been involved in due diligence before and have a broad understanding of global drug development and 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 as well as interacting with key regulatory authorities e.g. FDA, EMA, PMDA, and scientific advisory meetings
  • Ability to communicate complex scientific procedures with technical proficiency both orally and in writing.
  • Fluent level written and spoken English is a prerequisite
    • As a Scientific Director, we expect you to be the change management agent, a well-structured and dedicated team player, find it easy to build working relationships, and gain recognition amongst stakeholders with your proactiveness, integrity, and communication skills. Besides you have excellent analytical skills, systematic approach to identify root causes and propose innovative ways to solve problems. Finally, you thrive in navigating within an environment of tight timelines, high-complexity, non-standards, and diverse tasks in known and new therapy areas. 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 more than 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. You will join a team with a rapidly growing portfolio in a fast-paced environment and an informal atmosphere 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. 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. Contact For further information about the position, please contact Ana Mora Agudo at +45 3075 0292 or or Nicolai Frøslev Saabye at +45 3075 4135. Deadline 19 February 2023. Applications will be reviewed continuously when received and candidates may be called for interview before the deadline. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. You do not need to attach a cover letter to your application but please include a few sentences about why you are applying in your resumé or 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.


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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 24.1.2023, men kan have været deaktiveret og genaktiveret igen.

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