Regulatory Affairs Director
In anticipation of the highly changing regulatory needs within Galecto Biotech, our new colleague will provide specialist regional and local expertise and strategic leadership.
Based in Copenhagen, Denmark, with travel across the EU and to the United States, working closely with colleagues within Research, Clinical, Non-clinical and CMC, the Regulatory Affairs Director will have specific responsibility for:
- Defining the global regulatory strategy and leading or contributing to regulatory and policy discussions with a broad range of global and cross-functional stakeholders
- Providing strategic and tactical regulatory contributions to global development plans across all development and discovery projects for assigned drug candidate(s) in addition to other selected development projects
- Effectively working with cross department teams to achieve corporate business and departmental goals and objectives
- Ensuring that all projects are appropriately prioritized and regulatory plans are monitored, communicating progress/variance to Senior Management and ensuring that any risks (from emerging technical data, changing internal objectives or external threats) are mitigated
- Anticipating global regulatory changes and developing a proactive strategy accordingly
- Counseling and advising senior management on the status of global regulatory affairs strategies and tactics, procedures and practices, focusing on regulatory and policy across all major jurisdictions
- Life Science Degree and strong regulatory work experience
Skills & Experience
- Recent direct experience with development of medicines development is essential and includes leading EU and FDA regulatory authority interactions on clinical development and regulatory frameworks for approval
- Experience with EU regulatory affairs strategy, including direct interactions with a variety of stakeholders such as EMA, national Competent Authorities, FDA and others as needed
Other Candidate Requirements:
- A team player, but also able to act independently where needed. At the same time, the RAD must understand and embrace being part of a team and working collaboratively with others
The Successful Candidate Will Need to Be:
- an open communicator and influencer
- proactive and a driver
Galecto Offers A competitive salary package including annual bonus and flexible working arrangements.
A challenging position that will be central to developing the strategy for all our exciting programs in collaboration with dedicated and inspiring colleagues – all with comprehensive experience from their respective fields.
Place of work will be our Copenhagen office situated in COBIS, Ole Maaloes Vej 3, Copenhagen N.
Contact and Application
For further information, please contact Executive Assistant Dorte Danneman on firstname.lastname@example.org or +45 51500560.
Deadline for submitting your written application in English is November 20th, 2019 to email@example.com.
Galecto Biotech is a biotech company with offices in Montreal, Gothenburg, Edinburgh, London and Copenhagen. Galecto Biotech develops galectin modulators for the treatment of severe diseases, including fibrosis, cancer and inflammation. Our most advanced program is in clinical Phase IIB for the treatment of Idiopathic Pulmonary Fibrosis.