AOP Orphan is a European pioneer in the development, marketing and distribution of medicines for people with rare and complex diseases.To enhance our team in Vienna Headquarters we are looking for a:
Regulatory Affairs CMC Manager (f/m/d)
- Natural science/scientific background (HTL, FH, university) and several years of professional experience in below fields
- Profound knowledge of GMP and CMC regulations/guidelines
- Experience in writing / reviewing IMPDs and CTDs (Module 3)
- Knowledge of RA procedures and submissions
- Practical experience in CMC development of small molecules, oral solid dosage forms or parenteral products (injectables, lyo) - synthesis, formulation, manufacturing, analytics
- Strong communication and presentation skills in English and German
- IT skills (MS Office, Adobe Acrobat, alternatively MS-Project)
As part of our Pharmaceutical Development team you will play a key role in bridging CMC-related development and RA submission activities from pharmaceutical development to life cycle.
Ready for an ambitious job?
- You are responsible for creating processes for RA-CMC intelligence as an interface between the CMC development and RA submission department.
- You are aware of Module 3.2.S/P CMC-related guidelines.
- You define the strategy for CTD Module 3 content for new and already existing drug products.
- You write sound scientifically and regulatory justifications for changes to existing dossiers.
- You assess CMC-related documentation and translate it into a CTD, suitable for a smooth authority submission and assessment process.
- You interpret authority feedback in a way to identify potential missing data, define strategy for and author responses during a deficiency process or life cycle/variation process.
Able to align?
- You work and collaborate with our CMC Leads in a dynamic team.
- You ensure effective communication between CMC Leads and RA-department as well as Quality Management.
- You are strongly able to align CMC strategies for our products with the RA department.
Looking for an agile environment?
- You enjoy working in a high-performing international environment.
- You prefer a high degree of independence and responsibility for assigned projects.
- You are keen to manage multiple projects and being able to prioritize and self-manage.
The gross monthly salary provided for this function is a minimum of EUR 4.000.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.
Take this AOPPORTUNITY and apply now.
+43 1 503 72 44-62