Regulatory affairs specialist - F/M/X
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!
We are looking for a Regulatory Affairs Specialist to join Amaris and work for one of our clients, a leader in its sector.
??Your responsibilities:
Responsible for the legal aspects of the study, as well as the drafting, submission, and validation of regulatory documents. The main point of contact for regulatory authorities, ensuring that products are manufactured and distributed in compliance with the appropriate legislation.
- Drafting of documents, submissions, renewals in accordance with the requirements of regulatory affairs authorities to obtain the right to issue the CS (Certificate of Safety) or to update it.
??Your qualifications:
- Degree: Master's or Pharmacist (or Doctor).
- Schools: University or pharmacy studies.
Specialties:
- Possibility of specialization based on the product (medicine, medical devices, cosmetics...), local level (subsidiaries)/global level (headquarters), countries/regions (EMEA/Asia...).
??Our corporate culture:
Agility: Evolve in a flexible, dynamic, and stimulating environment.
International: Benefit from international collaborations and numerous mobility opportunities.
Intrapreneurship: Get involved in parallel initiatives or develop your own Business Unit.
Listening Management: Benefit from personalized support throughout your professional journey.
Amaris Consulting is committed to diversity and inclusion. We welcome applications from all qualified individuals, regardless of gender, sexual orientation, race, ethnic origin, beliefs, age, marital status, disability, or any other characteristic.