Senior Manager Regulatory CMC Small Molecule Development - NCE & ADC (all genders)

☞ Merck Group

Vue: 223

Jour de mise à jour: 24-10-2024

Localisation: Darmstadt Hesse

Catégorie: R & D Science La main doeuvre

Industrie: Pharmaceuticals

Niveau: Mid-Senior level

Type d’emploi: Full-time

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le contenu du travail



A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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 regulatory Chemistry, Manufacturing and Control (CMC) activities. You develop and are accountable for the global regulatory CMC and CMC dossier strategy. Furthermore, in being responsible for leading the content of the CMC dossier you act as liaison between Global Regulatory Affairs and CMC technical functions for new chemical entities from clinical phase I, II, III, first registration until launch (incl. phase IV) and Antibody Drug Conjugates (ADCs) (ADC DS, ADC DP, drug linker) until end of clinical phase II and for the drug linker until launch. This encompasses the accountability for strategic planning, authoring, review and approval of all regulatory relevant quality documents (e.g. MAA/NDA, IMPD/IND, Scientific Advice documentation, Answer to Objections). You are accountable for evaluation, interpretation and translation of the country regulatory requirements into CMC/technical requirements and to provide them proactively as prospective advice to the CMC functions/laboratory heads in analytical development, formulation development, drug substance development, and others e.g. non-clinical development. Furthermore, you are accountable for CMC topics in the context of Health Authority interactions/meetings. In addition, you contribute to risk and gap assessments and perform an expert assessment of in-and out licensing projects for business development (Due Diligence).

You are a permanent member in the Global Regulatory Strategy team, the CMC project team and other international and interdisciplinary working groups.

Who you are:
  • University degree in pharmacy or chemistry or life science, Ph.D. beneficial
  • Minimum of 5 years of pharmaceutical industry or health authority experience, with at least 3 years of global CMC regulatory experience
  • Excellent communication skills including interaction with all levels of the organization
  • Broad knowledge of regulatory CMC requirements (EU, US, ICH and other relevant guidelines), IMPD/IND requirements and EU as well as US Pharmacopoeias and GMP regulations
  • Experience in Health Authority interactions
  • Excellent written and spoken communication skills in English


What we offer: With us, there are always opportunities to break new ground. 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

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Date limite: 08-12-2024

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