stillingsbetegnelse:
Experienced/Senior RA Project Manager for Supply Chain Coordination

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Novo Nordisk Regulatory Affairs (RA) is seeking a experienced Project Manager for our team in Søborg, Regulatory Affairs Diabetes Coordination. If you thrive in a dynamic and challenging environment with focus on regulatory strategy, planning, execution and handling many global stakeholders, this job offers you the opportunity to be responsible for the regulatory part of Novo Nordisk manufacturing capacity projects and projects where Novo Nordisk agree with local contract and licens manufacturers to produce selected Novo Nordisk products. About the department Diabetes Coordination works with manufacturing site approvals to ensure supply flexibility and the availability of medicine to Novo Nordisks patients world wide. We support country transfers and follow up on submissions and approvals with our affiliate offices. We make early assessments of the regulatory impact of investment projects across Novo Nordisk. And we act as regulatory project managers for cross functional projects for establishment of new manufacturing sites e.g.building of a new factory in Russia and a filling plant in Denmark Site Hillerød. We are a newly established team, who aim at gluing cross functional activities together to ensure early input to the supply strategies. Our responsibilities include outlining the regulatory strategies to plan and manage the regulatory submissions to obtain and maintain marketing authorisations worldwide. This is done through, close collaboration with production, supply chain planning, affilate offices, labelling and regulatory product groups. Furthermore we are involved in several taskforce to ensure optimal use of or adjustment of our procedures and systems. The job You will be responsible for managing the regulatory activities related to supply chain projects including outlining the regulatory strategies, planning the regulatory submissions and securing the approvals. You will be responsible for preparing status meetings and presentations to management and to act as one point of entry to Regulatory Affairs for RA assessments on capacity projects and supply chain requests. You will be involved in making scenarios for fast approvals of products to specific coutries taking the end to end value stream into consideration. This means that you are able to understand the supply chain strategy,collect, analyse and understand the requlatory requirements and hereby understand the RA implications and oppertunities. You will be responsible for communication of the overview of all RA tasks from start to end and be able to create the RA implementation plan. You will ensure execution and implementation by close follow up with affiliate offices. You will be part of a highly dedicated team that secures timely interaction with relevant stakeholders both internally in RA HQ, with our manufacturing sites, our supply chain planning department and relevant affiliate offices. You will work in a fast-paced environment where no days are alike. You will be expected to take lead and to provide regulatory options to support decision making. We trust in your sense of responsibility and commitment to deliver excellent results and we offer a flexible working environment. Qualifications You hold a master’s degree in pharmacy, supply chain, engineering or similar. You have at least five years of project management experience from larger projects and preferable experience from international regulatory environment. You have a proven track record in making strategies/scenarios and set tangeable goals.You are structured, you challenge and argue based on data. You have demonstrated that you can listen and work with many different cultures. The job requires that you are an excellent communicator managing relations with stakeholders across the organisation on all levels with ease. You are a proactive problem solver and you bring a can-do attitude and a good sense of humour even when the pressure is

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark