Home-Based - CMC RA Manager - New Biotech Products

My client is a Drug Originator that has been being in the business since ca. +15 years, and has already several products on the market. This firm offers a very trustworthy environment, where you can really plan a long-term, solid career.

Thank to his strong background, the company has been investing in the development of new biotech drugs, that as CMC Regulatory Affairs Manager you will support from the early stages.

CTA/IND activities will therefore be your daily bread and butter, and you will frequently work on very challenging scientific questions. You will never get bored at this!

Already before COVID the company offered generous amount of homeoffice days, part-time options, and flexible working times. In fact, you can take this role in remoting, already from your first working day.

This flexibility is really a great new, so if you are interested in principle, apply today!

Your Main Tasks:

• Interacting with the relevant Health Authorities (Mainly EMA&FDA) on regular basis, with the sight of developing a business sounded CMC Registration strategy and correctly maintaning the existing licenses
• Strong cooperation with the clinical department
• Representing the CMC registration strategy at cross-functional projects
• Composing the relevant modules 2.3 and 3 for your assigned development projects
• Supporting your regulatory colleagues in all M2.3 and M3-related matters
• Performing some life cycle tasks

Location: Remote-Work

Starting Datum: ASAP

Contract Type: Permanent, unlimited position. You will be directly hired by my client

Salary: Negotiable

Your Profile:

• Long-term experience as CMC Drug Registration Manager, that is, in composing M2.3 and M3 for drug registration activities
• Mandatory: Your place of residence is located within Germany
• Hands-On and flexible approach to the regulatory work
• High communication skills

Happy to recommend someone? If you want to recommend someone, and we manage to place your referral, you will get a small 'thank you' gift from us!

My Contact Details:

i-Pharm Consulting

Dr. Emma Fleury, Recruitment Practice Manager für Recruitment in Regulatory Affairs

efleury@i-pharmconsulting.com

TEL: +49 89 3803 5861

Due to the high number of applications, we could be not able to come back to you, if your requirements are too distant from the one requested above. We thank you in advance for your understanding.