Director Regulatory Affairs

Director Regulatory Affairs

Exciting opportunity in a specialty biopharmaceutical company

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Inphena is looking for a highly motivated Director Regulatory Affairs where you will be providing regulatory leadership as global regulatory lead.

As Director Regulatory Affairs You will report directly to the CEO, You will be part of the team driving projects further and ensuring the best progress. You will be responsible for operational regulatory input as well as implementing regulatory strategies.

Your main tasks are:

Global regulatory strategy: Develop and provide regulatory guidance and strategies for optimal drug development and marketing authorizations globally. Collaborate cross-functionally to facilitate and optimize the registration process

Clinical trials: Conduct and supervise regulatory activities and submissions relating to the successful execution of clinical trials

Regulatory submissions: Planning and coordinating all aspects of regulatory submissions. Lead regulatory communications regarding and submissions of clinical trial applications, health authority advice, marketing applications, and variations/post-approval changes

Regulatory intelligence and policies: Support the company through regulatory intelligence efforts and contribute to internal regulatory policies and procedures to achieve best practices.
Stay abreast of regulatory laws and guidances to identify possible impacts

Leadership and collaboration: Effectively working in a distributed environment with collaborations across locations and outsourced activities including writing and supporting regulatory communications

Your qualifications include several years of experience within Regulatory Affairs from the pharmaceutical/biotechnology industry or as a CRO. Writing and reviewing regulatory documents and resolving stakeholder differences and reaching a path forward agreement. The preparation of agency meeting briefing documents, submission(s), and handling regulatory agency interactions.

You have a Master’s degree in Pharmaceutical Science or a similar university degree.

You are a person with strong interpersonal skills, as you will serve as a major contributor and trusted leader of the project teams. Work independently and with an entrepreneurial mindset. You can think and manage strategically with attention to detail when needed, and a passion and a sense of urgency for developing important medicines for devastating diseases.

Inphena offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Inphena’s strategy to advance Inphena’s exciting pipeline.

Traveling: Some traveling is foreseen, but not extensive as many people now work well together using online meetings.

Domicile: DTU Science Park, Hørsholm, Denmark.

For more details about the job or the company, please contact CEO Jørn Duhn, at M: +45 21 75 19 25, E-mail: [email protected]. Client Manager Gert Vium Andersen, at M: +45 42 95 08 83, E-mail: [email protected]. All applications must be in English and are treated confidentially.