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- Aufgaben: Support CMC regulatory activities and manage documentation for product submissions.
- Arbeitgeber: Join a top 20 global pharmaceutical firm dedicated to innovative patient treatments.
- Mitarbeitervorteile: Full-time position with opportunities for growth in a dynamic industry.
- Warum dieser Job: Be part of a collaborative team impacting healthcare and compliance on a global scale.
- Gewünschte Qualifikationen: Technical assistant or bachelor's degree preferred; experience in pharma or regulatory affairs is a plus.
- Andere Informationen: Fluency in English and German required; additional languages are a bonus.
Das voraussichtliche Gehalt liegt zwischen 36000 - 60000 € pro Jahr.
Associate CMC Regulatory Affairs (m/f/x)
Location: Bavaria | Pharma
As part of the EU RACMC Team, the Associate Regulatory Affairs CMC will deliver essential operational support for CMC regulatory activities across the lifecycle of both development and commercial products, including biologics and small molecules. This position is integral to RACMC product teams, ensuring precise regulatory product management and maintaining compliance to achieve overarching project goals.
What will your tasks as “Associate CMC Regulatory Affairs (m/f/x)” be?
Authoring and Document Coordination
- Assist in creating and finalizing CMC regulatory documentation and dossiers for various submissions (e.g., Marketing Authorization Applications, Variations, Renewals).
- Oversee authoring workflows, including task coordination, action item follow-ups, and logistics for document check-ins.
- Ensure all documentation complies with formatting standards and aligns with the current style guide.
Health Authority Queries
- Facilitate the preparation of responses to health authority queries, including timeline management and coordinating input from contributors.
- Consolidate review feedback, manage follow-up activities, and ensure timely delivery of responses.
Lifecycle Management
- Support the regulatory lifecycle management of commercial products, including aligning country-specific documentation with global standards.
- Prepare CTD Module 1 submissions and conduct thorough quality and consistency checks of submission packages.
GMP Clearance Support
- Act as a key member of the GMP Management Team to coordinate global GMP clearance activities, ensuring on-time delivery of required documentation.
- Serve as a point of contact for global RACMC colleagues, external partners, and affiliates.
Database and Archiving
- Maintain and update regulatory databases (e.g., Veeva HAQ, Master ToC, JIRA, GRATIS, eQMS) to ensure accurate records for regulatory purposes.
- Archive or oversee the archiving of regulatory and project-related files.
Your requirements as a “Associate CMC Regulatory Affairs (m/f/x)”?
- Qualified as a technical assistant (e.g., PTA, MTA, CTA, BTA, lab assistant), nurse, or equivalent; a bachelor\’s degree is an advantage.
- Several years of experience in the pharmaceutical industry, preferably in regulatory affairs, CMC development, or within a Clinical Research Organization.
- A proactive team player with strong interpersonal and communication skills.
- Highly organized, detail-oriented, and capable of working independently.
- Proficient in computer applications (e.g., MS Office, document management systems, databases).
- Fluent in English and German, with an additional language being a plus.
Information about our client:
The company is one of the top 20 global pharmaceutical firms, operating in 16 European countries. With over 15,000 employees in 20 countries, the organization is dedicated to developing and delivering innovative treatments for patients in fields such as hypertension, thrombotic diseases, and oncology.
Are you interested in this position? Then you should apply now!
Email:
I look forward to your application!
Seniority level
- Associate
Employment type
- Full-time
Job function
- Health Care Provider
- Industries: Pharmaceutical Manufacturing and Biotechnology Research
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Associate CMC Regulatory Affairs (m/f/x) Arbeitgeber: SciPro
Kontaktperson:
SciPro HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Associate CMC Regulatory Affairs (m/f/x)
✨Tip Number 1
Familiarize yourself with the specific CMC regulatory requirements in both Germany and the EU. Understanding the nuances of these regulations will help you stand out as a knowledgeable candidate who can contribute effectively from day one.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those working in regulatory affairs. Attend relevant conferences or webinars to connect with potential colleagues and learn more about the latest trends and challenges in CMC.
✨Tip Number 3
Gain hands-on experience with document management systems and databases commonly used in regulatory affairs, such as Veeva or JIRA. Being proficient in these tools will demonstrate your readiness to hit the ground running.
✨Tip Number 4
Prepare for interviews by practicing responses to common questions related to CMC regulatory affairs. Highlight your organizational skills and attention to detail, as these are crucial for the role.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Associate CMC Regulatory Affairs (m/f/x)
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure you fully understand the responsibilities and requirements of the Associate CMC Regulatory Affairs position. Tailor your application to highlight relevant experiences that align with the tasks mentioned in the job description.
Highlight Relevant Experience: Emphasize your experience in regulatory affairs, CMC development, or clinical research. Provide specific examples of your past work that demonstrate your ability to manage documentation, respond to health authority queries, and support lifecycle management.
Showcase Your Skills: Clearly outline your organizational skills, attention to detail, and proficiency in computer applications. Mention any experience with regulatory databases or document management systems, as these are crucial for the role.
Language Proficiency: Since fluency in both English and German is required, make sure to mention your language skills prominently in your CV and cover letter. If you speak additional languages, include those as well to strengthen your application.
Wie du dich auf ein Vorstellungsgespräch bei SciPro vorbereitest
✨Understand CMC Regulatory Affairs
Make sure you have a solid grasp of CMC regulatory affairs and the specific responsibilities outlined in the job description. Familiarize yourself with the lifecycle of both development and commercial products, especially biologics and small molecules.
✨Prepare for Document Coordination Questions
Be ready to discuss your experience with authoring and coordinating regulatory documentation. Highlight any specific examples where you managed workflows or ensured compliance with formatting standards.
✨Showcase Your Teamwork Skills
Since this role requires strong interpersonal skills, prepare examples that demonstrate your ability to work effectively within a team. Discuss how you've facilitated communication and collaboration in past projects.
✨Highlight Your Organizational Abilities
Emphasize your organizational skills and attention to detail. Be prepared to explain how you manage multiple tasks and ensure timely delivery of responses to health authority queries or other regulatory submissions.
