Job Id
290098
Darmstadt, Hessen, Germany
Job Type
full-time, part-time possible
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That’s why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
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.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
US Equal Employment Opportunities
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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Please refer the Job description for details