Regulatory Affairs Director - Region North West Europe
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Ørestad
We invite you to assume a pivotal role as the Region North West Europe (NWE) Regulatory Affairs Director, where your influence will extend far beyond regulatory compliance. Your mission will be to steer our organization towards regulatory excellence, orchestrating timely approvals and optimal product launches in the region. If this aligns with your career aspirations and experience, we encourage you to submit your application today! The Position Your primary responsibility will be to ensure that our regulatory strategies align with the region's commercial priorities. You will safeguard patient safety through the oversight of pharmacovigilance performance and advancing healthcare innovation. You will also provide regulatory input and strategic guidance to key cross-functional stakeholders in supply chain, commercial, communication, legal, safety and RA for all drug supply related issues. Your other responsibilities will also include: Develop and drive the strategic direction for the Regulatory Affairs function in Region NWE ensuring priorities Offer regulatory expertise, leadership, and consultation to key stakeholders and ensure that regional business opportunities are identified and addressed from a Regulatory Affairs perspective Spearhead the alignment and optimization of pharmacovigilance processes across the region Oversee and ensure alignment of regulatory processes and systems across the region to drive development and increase positive impact Engage strategically with internal and external stakeholders, securing timely communication and regulatory reporting Qualifications We are searching for a colleague with expertise in change management, problem-solving, and stakeholder management. Strong planning and coordination skills are essential, as well as the ability to handle pressure, build trust, and motivate others. In addition to these abilities, demonstrating integrity, innovative thinking, and a profound understanding of the therapy areas are pivotal. We expect the ideal candidate to have: Master of Science degree in life sciences, pharmaceutical science, or a related legal field 8+ years of international Pharmaceutical Industry experience with an experience in an international regulatory environment Previous experience in interacting/negotiating with regulatory authorities internationally Solid matrix leadership experiences in both a strategic and operational Regulatory Affairs function About the Department Region North West Europe (NWE) is the largest region of International Operations in terms of business. We have around 2000 colleagues of which 100+ work for the Regional Office based in Ørestad, Copenhagen. Together we are all committed to step ahead and set the pace for better outcomes for patients and societies in the region. The position will report to the Corporate Vice President for the Clinical, Medical & Regulatory (CMR) organisation which supports the planning and execution of clinical trials as well as development and implementation of medical & regulatory strategies across all therapy areas and development phases. We worked highly collaborative with a wide range of internal and external stakeholders. 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 If you have any questions, please contact Corporate Vice President, Clinical, Medical & Regulatory Pernille Poulsen at [email protected]. Deadline Apply before 23rd fof October. 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. 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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Ørestad.
Jobbet er oprettet på vores service den 22.9.2023, 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.
- Øvrige
- Ørestad
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