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 we are looking for a:
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 we are looking for a:
CMC RA Manager (f/m/d)
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.
CMC RA Manager (f/m/d)
Professional Skills
Natural science/scientific background (FH, university) and several years of professional experience in below fields
You are aware of Module 3.2.S/P CMC-related guidelines.
Profound knowledge of GMP and CMC regulations/guidelines
Experience in writing / reviewing IMPDs and CTDs (Module 3) and answering authority questions
Hands-on experience in Manufacturing or Analytics in one of the CMC development areas like small molecules, oral solid dosage forms or parenteral products (injectables, lyo)
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 define the strategy for Module 3.2.S/P CMC-related content for new and already existing products and create high-quality gap analyses if necessary
You assess CMC-related documentation and translate it into a CTD Module 3.2.S/P, suitable for a smooth authority submission and assessment process
Like to take accountability?
You write sound scientifically and regulatory justifications for changes to existing dossiers (summary of change documents)
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
You create and maintain RA-CMC intelligence processes (guideline and submission databases) as an interface between the CMC development and RA submission department
Able to align?
You work and collaborate with our CMC Leads in dynamic teams
You communicate effectively with CMC Leads and RA department as well as Quality Management
You are strongly able to plan and 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 € 4.000.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.
The gross monthly salary provided for this function is a minimum of € 4.000.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.
Ihr Ansprechpartner
Angelika Drabek
+43 1 503 72 44-62
