• Ability to contribute to the dossier content and to support the life cycle management of regulatory Devices and Drug/Device combination activities.

• Ability to develop, prepare and implement successful regulatory strategies and dossiers.

• Experience in preparation and management of regulatory documentation, including full global submission roll outs (new product application) or large variations for medical devices and/or drug device combination products.

• Experience with life-cycle management activities within the medical devices and drug/device combination products including prefilled pens, electronic autoinjectors and pre-filled syringes in the EU/US and International markets.

• Understanding and awareness of global pharmaceutical and medical device legislation

• Awareness of regulatory affairs contribution to Pharma business

• Basic understanding of concepts of project management and Regulatory affairs

• Good written and spoken English communications.

• Ability to think strategically, to perform root cause analysis and to propose and drive continuous improvement.

• Normal and routine office duties (hours of work may be adapted to match the Global team in EU and US region)

• Position may require both domestic and international travel.

Education

• Degree in a Life Science related disciplines, Pharmacy, preferably higher degree (e.g., MSc in scientific discipline or M. Pharm or Masters in Regulatory affairs)

• 7-10 years of overall work experience in Pharma environment

• Competent authority or Academia/RD experience related to the role.

• Minimum 5 years of experience in regulatory affairs in medical devices and drug/device combinations.