Job description
Join Amaris Consulting and support one of our leading clients in managing its regulatory affairs activities.
Your responsibilities
- Manage the regulatory and legal aspects related to studies and products.
- Draft, prepare and submit regulatory documents and dossiers to the relevant authorities.
- Ensure the review and validation of regulatory documentation in line with applicable requirements.
- Act as the main point of contact for regulatory authorities and manage ongoing interactions.
- Prepare the documentation required to obtain, renew or update the relevant authorizations and certificates.
- Ensure that products are manufactured and distributed in compliance with applicable legislation and regulatory requirements.
- Monitor regulatory renewals and updates throughout the product lifecycle.
About you
- Master’s degree in Life Sciences, Regulatory Affairs or a related field, or a degree in Pharmacy.
- University education or a background in pharmaceutical studies.
- Previous experience in Regulatory Affairs within the pharmaceutical, medical device, cosmetics or another regulated industry would be an advantage.
- Good understanding of regulatory requirements and submission processes.
- Strong organizational skills and the ability to manage several regulatory topics simultaneously.
- Excellent communication skills and confidence working with different stakeholders.
What we offer
- An international community bringing together 110+ different nationalities
- An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibility
- A robust training system with our internal Academy and 250+ available modules
- A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
- At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support.
- Benefits: access to our gym club, lunch vouchers and free Spanish classes
- Remote policy: Possibility to work remotely 2 days per week
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.
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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 7,600 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!