Senior Manager - CMC Dossier Leadership - NCEs (all genders) limited for 2 years

Posted 01 Apr 2019

Darmstadt, Hesse - Germany

Req Id 189533

Details

A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your role:
You are responsible in this role to lead and drive CMC regulatory activities, lead the CMC dossier content and interaction with CMC technical functions for concerned molecules of specific focus areas. In particular these areas are new chemical entities from Phase I, II, III, first registration until launch (incl. Phase IV). This encompass responsibility for the CMC section of the CMC strategy document and contribution to risk and gap assessment, strategic support and advice. Furthermore, you contribute to Health Authority interactions on CMC regulatory topics and activities e.g. the CMC regulatory/dossier strategy, strategic planning, authoring, review and approval of all regulatory relevant quality documents (e.g. MAA/NDA, IMPD/IND, Scientific Advice documentation, Answer to objections). Furthermore, you are participating in Health Authority Meetings as appropriate. You are responsible for translation and interpretation of the country regulatory requirements into CMC/technical requirements and to provide them as prospective advice to the CMC technical functions/laboratory heads in analytical development of drug substance, and drug product, formulation development of drug product, drug substance development, and others e.g. non-clinical development. You are securing the CMC Regulatory Compliance for the development projects and being responsible for performance/preparation of regulatory compliance audits/inspections at the sites including CMOs. In addition you perform an expert assessment of in-and out licensing projects for business development (Due Diligence) and being a permanent member in CMC project teams, dossier generation team, other international and interdisciplinary working groups.

 

Who you are:

• University degree in pharmacy or life sciences, Ph.D. beneficial

• Minimum of 7 years of pharmaceutical industry experience, with at least 3 years of global CMC regulatory experience

• Professional experience in pharmaceutical development, analytical development, drug substance and drug product synthesis and/or global CMC regulatory affairs

• In depth knowledge of pharmaceutical legislation including pharmacopeial requirements for the pharmaceutical areas

• Broad knowledge of regulatory requirements for CMC (EU, US, ICH and other relevant guideline), IMPD/IND requirements and EU as well as US Pharmacopoeias and GMP regulations

• Experience in Health Authority interactions

• Understanding of related scientific areas (e.g. Toxicology, Pharmacokinetics)

• Experience in working with electronic document management systems

• Excellent written and spoken communication skills in English (knowledge of other European languages is an asset)

 

 


What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
 

Curious? Apply and find more information at https://jobs.vibrantm.com
 

Apply Now

Let’s stay connected

Do you want to receive company news and information about career opportunities tailored to your preferences? Sign up here. You want to check the status of your application or change your candidate profile? Enter our job portal.

Redirect

You have accessed https://www.emdgroup.com, but for users from your part of the world, we originally designed the following web presence https://www.merckgroup.com.

Let's go

Share Disclaimer

By sharing this content, you are consenting to share your data to this social media provider. More information are available in our Privacy Statement