Associate Director, RA Facility and Projects
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Søborg
Are you driven to advance your leadership journey in the realm of a worldwide pharmaceutical enterprise? Does the prospect of guiding a team comprising exceptionally skilled and motivated individuals from a variety of cultural and professional backgrounds ignite your passion? Do you want to contribute to driving regulatory strategies for projects from early phases to life cycle management of our products? If so, we invite you to explore the exciting opportunity of becoming an Associate Director – Facility and Projects, as part of our "Submission Excellence" team within Regulatory Affairs (RA) CMC (Chemistry, Manufacturing and Control) & Device. Apply now! The position We are seeking a leadership-oriented colleague who can provide direction and possesses a strong drive for collaborative success. As the Associate Director, you will be entrusted with daily leadership responsibilities for your team members. Your role will be to guide the team in delivering best-in-class regulatory strategies for the projects we support, ensuring swift submissions and approvals on a global scale. Key responsibilities include: Daily collaboration and support to global manufacturing sites on facility related changes Oversee initial regulatory strategies for capacity expansion projects and other strategically significant initiatives Leverage scientific expertise and regulatory experience to contribute to decision-making Provide leadership and guidance to a team of colleagues, ensuring effective management of day-to-day activities Collaborate closely with various stakeholders at all organisational levels Our guiding philosophy is straightforward: When you thrive and are appropriately challenged in your job, you are the best version of yourself and the most valuable colleague. As part of an organisation that serves as a strategic business partner throughout various stages of a product's life cycle, you will encounter stimulating prospects within your department and across the company. We anticipate that you will embrace this mindset as you foster your personal development and that of your team. Our organisation operates worldwide, and the role is located in Søborg, Denmark. Qualifications To be successful in this role, you need: Academic degree, ideally a Master's, in Pharmaceutical or Life Sciences, along with proven track record of relevant work history +5 years of experience in leadership roles within pharmaceutical operations is desired, ideally in Regulatory Affairs; however, other relevant backgrounds, such as manufacturing, are also considered Strong interest in developing people and teams, with a proven track record of positive results Excellent communication skills and be known as a leader who drives change and innovation Proficiency in English, both written and verbal As a person, you are an ambitious individual with a proactive mindset, taking the lead in overcoming challenges and guiding your team forward. Your strong business acumen empowers those around you through constructive feedback and guidance. Furthermore, your exceptional communication skills enable collaboration across all organisational levels, and you inspire others to excel while upholding product quality and patient safety without compromise. You need to prioritise efficiency with a LEAN approach, possess excellent organisational and strategic skills, and maintain composure under pressure. About the department RA CMC & Device is one of two head quarter based regulatory functions, with the responsibility to drive regulatory strategies for projects from early phases to life cycle management (LCM) of marketed products worldwide. Submission Excellence is a relatively new area, consisting of 4 departments. We have the overall purpose of driving a continuously ambitious LCM agenda to ensure flexibility in the supply network and to act as strategic partner to manufacturing and capacity expansion projects. We have a key role in setting the regulatory strategies for expansion projects, streamlining processes, and ensuring fast and efficient global roll out and approvals. “RA Facility & Projects” currently comprise of 8 colleagues, with the responsibility to define early regulatory strategies for capacity expansion projects or other strategic important projects going across the product portfolio. The team consists of scientific profiles with an extensive regulatory experience, along with strong project management and coordination skills. Close collaboration with colleagues across RA CMC & Device is required, as submission responsibility and overall product accountability lies with them. “RA Facility & Projects” also has the role to coordinate required documentation in the dossier related to facilities, equipment, and cleaning, which entails daily support to the global manufacturing sites, internal and externally and covers the full lifecycle from initial submissions to late LCM. 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 please contact Director Malene Østergaard Jørgensen, +45 30795844. Deadline 26th of November 2023. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline. 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 resume or CV. 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.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 26.9.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Søborg
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