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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.

Take this AOPPORTUNITY and


Your contact
Angelika Drabek
+43-664-88963746

Take this AOPPORTUNITY and apply now.

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

Take this AOPPORTUNITY and


Your contact
Angelika Drabek
+43-664-88963746