Job Description

Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win. Together with our partners around the world, WE MAKE HEALTHCARE BETTER! Tasks and Responsibilities Design, develop, manage, and execute highly effective project management plans regarding technical feasibility, risk management, resource availability and its allocation Act as SPOC for everything involving project design, organisation, timelines, and performance Consult with clients to develop regulatory strategies, identifying the most efficient and compliant pathways for bringing their pharmaceutical products to market Advise clients on the CMC data and information necessary to support dossier approval Perform gap analysis on existing dossiers for regulatory approval Prepare, review, and submit high-quality regulatory documents and submissions in close collaboration with client CMC functions, mainly to EU and US health authorities, including IMPD and IND Coordinate people, processes, and resources ensuring each project delivers, or exceeds, client and Arcondis expectations, and reflects Arcondis standards Manage and maintain excellent client and stakeholder relationships Collaborate with cross-functional multidisciplinary teams in multiple time zones and different cultures to ensure consistent value delivery Your Profile: Minimum of 5 years\' experience in CMC Regulatory Affairs within the pharmaceutical industries In-depth knowledge and understanding of EU and US CMC regulations and submission processes Demonstrated success in preparing and managing EU and US submissions and approvals Good understanding of Good Manufacturing Practices (GMP) Minimum 6 years professional project management experience gained in Pharmaceutical and/or MedTech organizations end-to-end value streams and associated regulatory requirements Highly experienced working knowledge and application of methodologies such as PMBOOK, PRINCE2, Agile / SCRUM, and common change management approaches to project management Demonstrable track record and passion for delivering your projects on time, in quality & budget Comfortable managing multiple and complex projects with excellent communication skills, leadership, and relationship management with Project stakeholders Collaborative, highly motivated and effective can-do team player with a problem-solving aptitude and outcome driven mindset able to work within and across multidisciplinary teams Talent for keeping the complex simple & communicate seamless across various levels of hierarchy Excellent written and oral communication skills in English Willingness to travel, including overseas Benefits Becoming part of a global consulting company with a start-up mindset Opportunity for continuous growth, improvement, and challenges Self-organizing and flat hierarchy Participation in shaping Arcondis\' culture and in building the team/community Please note that there may be occasional need to be present at the client\'s site.

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