Regulatory Affairs Expert for Pharmaceutical Products
2 days ago
We are seeking a highly motivated and experienced Regulatory Affairs Partner to join our team at Roche Pharmaceuticals A/S. As a Drug Regulatory Affairs Partner, you will play a crucial role in driving regulatory tasks and making a significant impact on our business.
Responsibilities:- Ensure compliance with regulatory legislations and procedures for assigned products in Denmark and Iceland.
- Coordinate and prepare document packages for regulatory submissions, including new products and Life Cycle Management submissions.
- Proofread regulatory texts in local language and ensure accuracy.
- Responsible for artwork changes related to Lifecycle Management, including manuscript creation, proofreading, and approval.
- Maintain corporate regulatory data and document management systems up-to-date.
- Stay abreast of regulatory changes and updates to secure compliance.
- Interact directly with regulatory agencies and provide timely responses to inquiries.
- Support the business and disease area teams with regulatory details, timelines, and information related to products.
- Collaborate with Roche HQ to coordinate Scientific Advises with Danish Health Authorities.
- Implement new systems and train new colleagues on regulatory procedures.
- A Master's degree in pharmacy, pharmaceutical sciences, or related fields.
- A strong personality with excellent communication skills.
- Systematic approach to work, flexibility, and strong interpersonal skills.
- Ability to work independently and as part of a team.
- Fluency in Danish and English, both spoken and written.
At Roche, we are a global leader in research-focused healthcare. We operate across 100 countries, driven by innovation, curiosity, and diversity. Our mission is to improve people's lives through healthcare solutions that address complex challenges.
Why Join Us?Rochester offers an inclusive work environment where every voice matters. We foster diversity, equity, and inclusion, representing the communities we serve. If you share our passion for exceptional care and want to make a meaningful impact, we invite you to explore this opportunity further.
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