Global Regulatory Lead, Regulatory Affairs

Ascendis Pharma

Hellerup, Denmark

Description

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

Do you want to work globally in an innovative company making products available for patients worldwide?

We offer you an exciting and challenging position in an entrepreneurial and international company, with a short line of command. As our new Global Regulatory Lead, you will be responsible for activities that are central to Ascendis Pharma’s global strategy, and you will work cross functionally to identify the best regulatory opportunities for bringing a new product to the patients.

Ascendis Pharma is a fast-growing, dynamic biopharmaceutical company with Headquarters in Denmark, that offers you room to grow and the freedom to take responsibility and make a difference for patients every day. As a member of our global team, you will work with highly skilled and passionate colleagues to advance our exciting product pipeline.

We are looking for an experienced Global Regulatory Lead, who will be responsible for strategy support to regulatory approvals, as well as development and life cycle management. You will also be involved in building up our internal standards and processes in support of global regulatory activities.

You will be responsible for:

Providing strategic and tactical regulatory contributions to global development plans and supporting implementation of regulatory strategies
Conducting and supervising regulatory activities and submissions relating to the successful execution of clinical trials
Driving and coordinating regulatory communications with and submissions to health authorities such as orphan drug applications, PIPs/PSPs, health authority advice, marketing applications and life-cycle management submissions on assigned development projects
Mentoring colleagues to perform optimally in their current role and to develop people to the next level
Working in a team environment with collaborations across locations and departments to ensure fulfillment of project goals

Requirements

Your professional qualifications

You have a minimum of 10 years of documented professional experience from a Regulatory Affairs position in the pharma industry. You must have extensive regulatory experience including IND/CTA, NDA/BLA/MAA, PIP/PSP, lifecycle management, labelling, interactions with Health Authorities, and experience in developing short- and long-term regulatory strategies. You can 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 as RA core team member driving BLA/NDA and MAA 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 excellent collaboration, communication, and sharing of knowledge.

As our new Global Regulatory Lead, you will be working in a well-established and team-oriented department, currently consisting of 8 experienced and dedicated colleagues supporting each other by actively sharing learnings and experience. You will be working closely together with Danish and US colleagues across Regulatory Affairs, Clinical Development, Clinical Operations, Pharmacovigilance and Global Drug Safety, Global Medical Affairs, Global Medical Strategy, Program Management, and with our global partners.

We will actively be supporting your professional development by providing appropriate training, hands-on experience, and the opportunity to learn from experienced colleagues.

Travel: 20-30days per year.

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