Senior Manager GRA CMC Small Molecules Development (all genders) at Merck KGaA

Darmstadt, Hesse, Germany -

Full Time

Start Date

Immediate

Expiry Date

07 Feb, 26

Salary

0.0

Posted On

09 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory CMC, New Chemical Entities, Antibody Drug Conjugates, Global Regulatory Affairs, CMC Dossier Strategy, Analytical Development, Drug Product Development, Drug Substance Development, Health Authority Interactions, Project Management, Communication Skills, Strategic Planning, Team Collaboration, Regulatory Requirements, Due Diligence, Expert Assessments

Industry

Pharmaceutical Manufacturing

Description

Your role: As Senior Manager Regulatory CMC, you will lead and drive global regulatory CMC activities for New Chemical Entities (NCE) and/or chemically synthesized drug-linkers for Antibody Drug Conjugates (ADC) during all clinical phases (I, II, III) and first registration until launch, as well as for post-approval development projects. You will develop and be accountable for the global regulatory CMC strategy as well as for the CMC dossier strategy and content. You will act as a liaison between Global Regulatory Affairs and CMC technical functions. This encompasses 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 will evaluate, interpret, and translate country regulatory requirements into CMC technical requirements and provide proactive advice to the CMC technical experts in analytical development, drug product development, drug substance development, and others. Additionally, you will provide strategic regulatory CMC advice to other global regulatory functions and will contribute to the global regulatory strategy and submission planning. You will be a permanent member in CMC project teams and global regulatory project teams, as well as other international and interdisciplinary working groups. In addition, you will be involved in Health Authority interactions/meetings as regulatory CMC lead and will perform regulatory CMC expert assessments of in- and out-licensing projects for business development (Due Diligence). Who you are: University degree in pharmacy, chemistry, or life science; Ph.D. is beneficial Minimum of 5 years of experience in pharmaceutical industry or at Health Authorities, with at least 3 years in regulatory CMC Experience with New Chemical Entities and/or chemically synthesized drug-linkers for Antibody Drug Conjugates Broad knowledge of global regulatory CMC requirements (EU, US, JP, CN, BR, and others) for clinical trials and for first registration Experience in driving regulatory CMC activities and in authoring of CMC dossiers Excellent written and spoken communication skills in English Passionate about collaborating within teams, overcoming project challenges, and developing solutions collaboratively This position offers a hybrid work format, allowing for a combination of on-site and remote work. Recruiter: Larissa A Krumb Department:HC-RD-RCA Reg CMC Small Molecules Developme Job evaluation:AT - Expert 3

Responsibilities

Lead and drive global regulatory CMC activities for New Chemical Entities and drug-linkers for Antibody Drug Conjugates during clinical phases and post-approval. Develop and be accountable for the global regulatory CMC strategy and act as a liaison between Global Regulatory Affairs and CMC technical functions.