Senior Manager Regulatory CMC - Small Molecules Development (all genders)

at  Merck KGaA

64293 Darmstadt, Hessen, Germany -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate18 Jul, 2024Not Specified18 Apr, 20243 year(s) or aboveGood communication skillsNoNo
Add to Wishlist Apply All Jobs
Required Visa Status:
CitizenGC
US CitizenStudent Visa
H1BCPT
OPTH4 Spouse of H1B
GC Green Card
Employment Type:
Full TimePart Time
PermanentIndependent - 1099
Contract – W2C2H Independent
C2H W2Contract – Corp 2 Corp
Contract to Hire – Corp 2 Corp

Description:

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.

Responsibilities:

As Senior Manager Regulatory CMC, you will lead and drive global regulatory CMC activities for New Chemical Entities (NCE) and/or 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, life science, or equivalent; 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 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 EnglishPassionate about collaborating within teams, overcoming project challenges, and developing solutions collaboratively

  • What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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!
    Apply now and become a part of our diverse team


REQUIREMENT SUMMARY

Min:3.0Max:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

64293 Darmstadt, Germany