stillingsbetegnelse: Regulatory Lead on Manufacturing Site Investment

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Join a fast-changing environment where engaged people do their best every day to obtain and maintain market authorisations worldwide for all Novo Nordisk medicine across the globe. In Regulatory Affairs - Chemistry, Manufacturing and Control (CMC) Diabetes we work with all our marketed products, all our development projects and have a high focus on maintaining an optimal use of our manufacturing sites. That makes Regulatory Affairs (RA) a truly interesting place to work, but also quite challenging. Are you up for the challenge? About the department RA CMC Diabetes is situated in the Novo Nordisk project house together with other regulatory affairs functions in Søborg. We are a group of approx. 40 highly skilled and dedicated people involved in every CMC aspect concerning the regulatory files and licenses, as well as providing regulatory input during the various phases of drug development. We work very closely with stakeholders within Novo Nordisk headquarters, manufacturing sites inside and outside Denmark, our affiliated offices and health authorities around the world. The area is organised into three departments. We are currently looking for a Regulatory Lead to join our CMC Diabetes Coordination department of 9 colleagues. The position As Regulatory Lead you will be responsible for defining and coordinating regulatory activities on a portfolio of Manufacturing Site Investments and Projects and ensuring timely engagement with Supply Chain Planning, Manufacturing development functions, supporting Manufacturing functions and Regulatory Affairs on a global level. Furthermore you will be accountable for setting regulatory strategy for the Product Supply capacity projects and ensuring alignment of the regulatory strategies across product portfolios. You will provide expert insight across product portfolios and build the necessary regulatory expertise and robust regulatory submission plans to ensure fast approvals. You will be identifying trends in the global regulatory environment and utilizing the gained knowledge to obtain fast approvals. You will represent Regulatory Affairs in capacity project teams/global project teams. Here you ensure regulatory deliverables according to agreed timelines, cost and quality. You will provide timely and proactive regulatory impact assessment to seeks timely solutions and drive innovation.. The position has global reach within the portfolio of Manufacturing Capacity Projects and will drive negotiations with Health Authorities where needed. The position will require travelling to affiliate offices and Health Authorities (up to 10%). The position holder requires high level of initiative and ability to act with impact. You will be required to keep updated with knowledge on regulatory requirements/trends and seek input externally through trade organisations and conferences. You are expected to establish thorough understanding of the regulatory process, plans for Regulatory Affairs and overall project activities, constantly balancing the different stakeholder needs and priorities, while maintaining a well- established network. Qualifications You have a MSc within Biology or within a relevant field of Health Science .You have global regulatory understanding and experience from pharmaceutical manufacturing. You are an experienced project manager with proved track records in executing complex projects within tight timelines. You have experience interacting directly with regulatory authorities on an international scale and have excellent people collaboration and communication skills that help create high-performing teams and successfully drive your projects across geographical, cultural and organisational borders. Furthermore, you work independently for the success of your projects, but do it with respect for portfolio priorities. As a person you apply an innovative approach and never lose strategic focus. You are result oriented, well-organized with

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse:
Arbejde inden for biologi, botanik, zoologi og beslægtede områder

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark