Regulatory Affairs Senior Manager
Job ad heading Are you experienced within clinical and non-clinical regulatory affairs and are you passionate about finding new pathways for approval of combination products then this might be an interesting job for you
Ascendis Pharmais a fast-growing, dynamic biopharmaceutical company with Headquarters in Hellerup, Denmark that offers you room to grow and the freedom to take responsibility and make a difference for patients every day. You will be involved in activities that are central to Ascendis Pharma’s strategy in teams of highly skilled and passionate colleagues to advance our exciting product pipeline. You will lead operational regulatory input as well as implementing regulatory strategies across Non-clinical and Clinical in collaboration with the rest of the regulatory team in an entrepreneurial and international company with a short line of command.
You will be responsible for:
- Providing strategic and tactical regulatory contributions to global development plans and support implementation of regulatory strategies
- Planning and coordinating regulatory submissions necessary to support all types of regulatory applications, e.g. clinical trial applications, marketing authorizations, variations/post-approval changes – ensuring efficient regulatory interactions with health authorities
- Effectively working in a team environment with collaborations across locations and departments to ensure fulfillment of project goals
- Supporting the company through regulatory intelligence activities and contribute to internal regulatory policies and procedures to achieve best practices
Your professional qualifications
You have a minimum 5 years of documented professional experience from a Regulatory Affairs position in the Pharma industry. You are able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.
You hold a relevant master’s degree within Life Science, and you have experience working as a RA project member of BLA and/or NDA filings, ideally including combination products. You are proficient in English at a professional level, both written and spoken.
As a person, you thrive in being challenged and working in collaborative environments. You are pragmatic, flexible, focused and solution-oriented. In addition you know how to build partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise, and the provision of appropriate resources.
Travel: 5 - 15 days per year.
Office location: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn, Hellerup with a view to the harbour, the canals and the sea.
Applications will be evaluated when received, so please apply as soon as possible.