Project Manager – Regulatory, Compliance & Market Access for Pharmaceutical industry

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 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.

We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviors.

We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it's our way of life. Our motto, We make healthcare better, reflects the unwavering commitment we have to improving the lives of people through the work we do.

Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.

We embrace diversity and inclusivity, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our shared purpose.

We are currently seeking a dynamic and results oriented project manager with good knowledge of European markings oriented Regulatory Affairs for pharmaceutical products. This is an opportunity to join a fast-growing consulting group that values entrepreneurial spirit and offers an exciting journey of growth.

Level: Mid to Senior

Location: Malaysia

Work mode: Hybrid, Home office or on client site based on project needs

Start date: Q1 2024

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
• Ensure each project meets required results on-time-in-full and within budget and scope
• Analyse and document client requirements and secure alignment of Arcondis and client teams to those requirements.
• 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
• Become a valued contributing member of Arcondis Service Delivery Networks for knowledge sharing between peers and Project teams to enhance effectiveness and development of a fast-growing organisation.

Qualifications

• Highly experienced working knowledge and application of methodologies such as PMBOOK, PRINCE2, Agile / SCRUM, and common change management approaches to project management
• Deep understanding and working knowledge of the regulatory framework governing life science and healthcare in Europe is a must. This includes knowledge of the European Medicines Agency (EMA) regulations, and other relevant directives.
• Having managed end-2-end market expansion or access projects in those industries is a big plus.
• Minimum 6 years professional project management experience gained in Pharmaceutical and/or MedTech organizations end-to-end value streams and associated regulatory requirements
• 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 internationally.

Why Arcondis

Arcondis will provide you with a highly professional environment embedded in a transparent and people-oriented culture that allows you to make a sustainable impact and to realize your potential. We offer you:

• An opportunity to shape the future of healthcare by spearheading transformative deals.
• A collaborative and innovative work environment, where your ideas are valued, and your contributions make a significant impact.
• Flexible working environment, enabling work-life balance.
• Attractive compensation package, inclusive of performance-based incentives that reward exceptional achievements.
• Professional growth and development opportunities.

Please consider applying only meeting the location requirement - Kuala Lumpur and Selangor area and a working knowledge of European regulatory framework.

International applications will not be considered due to a hybrid, partly on-premises work mode.