(Senior) Global CMC RA Manager

J oin the Boehringer Ingelheim team and make a difference in the world of pharmaceuticals!

Are you passionate about advancing healthcare and making a positive impact on patients' lives? Boehringer Ingelheim is seeking a dedicated and innovative (Senior) Global CMC RA Manager for Chemical products to join our dynamic team. As a global leader in the pharmaceutical industry, we offer unparalleled opportunities for collaboration, growth, and international exposure.

In this role, you will play a crucial part in the development and delivery of our cutting-edge Chemical products while also contributing to the continuous improvement of processes and standards within Regulatory Affairs. If you have a strong background in small molecules including various dosage forms and a desire to work with a diverse team of professionals, we invite you to explore this exciting opportunity at Boehringer Ingelheim.

This position can be filled in different countries.

Ihre Aufgaben

• Have worldwide responsibility for CMC-regulatory aspects of Development Projects, Strategic Products, Established Products, and Strategic Projects requiring extraordinary regulatory expertise within Group Global CMC Regulatory Affairs.

• Support complex, non-standard projects with multiple indications and/or formulations, potentially involving licensing partners.

• Serve as the expert for regulatory topics within BI, monitoring developments in your assigned area of strategic importance, assessing impacts on BI, and informing colleagues in RA and affected functions.

• You will represent the department in international cross functional project teams, proactively define global regulatory submission strategy for the development of our new chemical entities and provide regulatory advice regarding global CMC regulatory requirements to achieve development objectives.

• For in-licensing opportunities you will support in-depth evaluations by reviewing CMC documentation and participating in due diligences providing your CMC regulatory assessment.

• Share best practices and grow your colleagues via knowledge management training and advice.

• You will plan, define, review, manage and compile global Module 3 documentation for INDs / Clinical Trial Applications and Biologics License Applications / Marketing Authorization Applications.

• Furthermore, you will maintain current knowledge and expertise within the global CMC regulatory environment (ICH, FDA, EMA, PMDA, China and Emerging Markets) for topics related to Biologicals and Medical Devices / Combination Products.

Ihr Profil

• As our future Global CMC RA Manager for New Chemical Entities , you will need:

• A Master's Degree (e.g. MBA, MSc) or Diploma Degree in Chemistry, Pharmacy, Biochemistry, Biology or comparable field , PhD would be beneficial

• Several years of experience in CMC RA for new chemical entities as well as for Medical Devices / Combination Products, with profound knowledge of global CMC regulations for new chemical entities, knowledge of further modalities like synthetic peptides and oligonucleotides is a plus

• Proven leadership skills, with experience leading international teams with the ability to lead and motivate people in cross-functional teams and set directions in a rapidly changing environment, being agile and team-oriented

• Strong inter-cultural competence and an integrative personality

• Excellent priority setting and decision-making abilities

• A passion for patient-focused drug development

• Fluency in English (written and spoken); German language skills would be a plus

  Additional requirements for the Senior role:

• In-depth knowledge in Regulatory Affairs, Pharmaceutical Development, Pharmaceutical Production, Quality Assurance, and leadership in an international environment Substantial knowledge of international CMC regulatory requirements (ICH, FDA, PMDA, EU, China, and emerging markets)

• Experience working with CMOs and external partners

• Extensive knowledge in CMC development and/or production/control of new chemical entities , with a sound scientific understanding of products and processes

Kontakt

If you have any questions about the job posting or process - please contact our HR Direct Team,

Tel: +49 (0) 6132 77-3330 or per mail: hr.de@boehringer-ingelheim.com