Regulatory Affairs Expert (m/f/x)
Negotiable
Preclinical
Bayern
Permanent
Hybrid

Regulatory Affairs Expert - Pharma (m/f/x) | hybrid

We are looking to strengthen our team with a Regulatory Affairs Specialist (m/f/d) who will support our clients in regulatory approval projects.

What are your responsibilities as a " Regulatory Affairs Expert (m/f/x)"?

  • Document Creation and Organization: You will be responsible for creating, organizing, and managing documents, particularly CMC documentation, US micro packages, quality management system and validation overviews, as well as statements and confirmations.
  • CTD Module Development: You will create CTD modules and conduct CTD reviews to ensure the quality and completeness of the documentation.
  • Site Accreditation and Registration: You will manage the submission and receipt of site accreditation and site registration.
  • Client and Regulatory Inquiries: You will evaluate and respond to inquiries regarding regulatory affairs topics to ensure smooth communication.
  • Handling of Deficiencies: You will be responsible for addressing deficiency complaints and developing solutions to optimize processes.

What requirements should you bring as a "Regulatory Affairs Expert (m/f/x)"?

  • A degree in pharmacy, life sciences, or a related field.
  • In-depth knowledge of regulatory affairs, particularly in the creation of submission documents and CTD documentation.
  • Experience in communication with regulatory authorities and clients.
  • Strong organizational skills and a structured approach to work.
  • Excellent communication skills and ability to work with cross-functional teams.
  • Fluency in both German and English.

What does the company offer you?

  • Contract type: Permanent full-time contract.
  • Vacation: 30 days/year
  • Home office: Up to 40% remote/mobile.
  • Working hours: 40 hours/week.
  • A dynamic work environment with a flat organizational structure
  • Opportunities to quickly take on responsibility and make a meaningful impact
  • Start date: As soon as possible

My contact details:

Are you interested in this position? Then you should apply now! If you desire additional or alternative job opportunities, I also welcome your application. I look forward to receiving your application!

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We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference. We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference.