Regulatory Affairs Manager
Vor 2 Tagen
Job Summary:
We are seeking a highly skilled Regulatory Affairs Manager - CMC to join our team at SciPro. As a key member of our Regulatory Affairs department, you will be responsible for supporting our clients in the preparation and submission of regulatory documents for pharmaceutical products.
Key Responsibilities:
- Creation, organization, and administration of documents (particularly CMC documentation/US "Micro package" ) for national and international regulatory projects.
- Preparation of CTD modules and conduct of CTD reviews.
- Submission/receipt of Site Accreditation/Site Registration.
- Assessment/responding to customer and regulatory authority inquiries regarding Regulatory Affairs topics.
Requirements:
- Successfully completed a scientific degree (e.g., Pharmacy, Biology, Chemistry, Food Chemistry), BSc, MSc, MDRA.
- Several years of professional experience/knowledge in drug approval (national, EU, global). Knowledge of GMP compliance is advantageous.
- Experience in Regulatory Affairs CMC.
- Several years of experience in preparing CMC dossiers.
- Prior experience with tech transfer processes and knowledge in Regulatory Affairs Intelligence is a plus.
- Strong communication and team skills.
- Ability to work independently with high dedication.
- Excellent communication skills, confident demeanor, motivation, team spirit, and assertiveness.
- High scientific methodological competence combined with customer orientation.
- Excellent German and English language skills.
About Our Client:
Our client is a leading pharmaceutical company with a global presence in European and non-European countries. They have a portfolio of around 20 well-known pharmaceutical products and are known for their constant growth within the industry.
Application Process:
- CV to be submitted to the hiring manager.
- Call with a presentation of the company.
- Discussion of other exclusive positions tailored to the candidate's profile.
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