Regulatory Affairs Project Manager [F/M/X]

工作内容

Job description

The Regulatory Affairs Project Manager (RAPM) should possess strong project management skills within the field of Regulatory Affairs (RA). This role is not focused on regulatory registration or medical product specifics but rather on coordinating activities across countries.

Key Responsibilities
Oversee the preparation of regulatory submissions, adhering to applicable guidelines and timelines.
Monitor program reporting and assist in reporting to functional leadership using Daily Management Key Performance Indicators (KPIs).
Collaborate with cross-functional teams to align project timelines and deliverables.
Ensure the successful execution of the PMO’s strategy, responsibilities, services, and deliverables.
Establish effective collaboration among stakeholders, including clinical, marketing, demand planners, and RA regional managers.
Communicate project development progress transparently to relevant parties.
Facilitate regular project status meetings and update stakeholders on milestones.
Provide global regulatory advice to project teams and other stakeholders.
Support the development and implementation of regulatory strategies and plans.
Align strategies with business objectives and compliance goals.
Integrate project management methodologies into regulatory processes.
Candidate Requirements
Strong English communication skills.
Analytical skills to calculate resources and complete projects.
Advanced Excel skills, Power BI, and PowerPoint.
Minimum of 3 years in a regulated environment, preferably in multinational companies.
Practical experience in project management within RA.
Ability to create charts and assessments.
Specific tasks and examples of past roles to be included in the motivation letter.
Background in multinational companies and regulated markets.
Open to various tools and solutions.

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7500 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here’s what our recruitment process looks like:

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate’s shoes to ensure they have the best possible experience.
We look forward to meeting you!