This position is limited for 2 years.

Tasks & responsibilities

• In this function, you will manage CMC regulatory activities for small molecules in development.

• Further, you will also manage CMC regulatory activities for approved small molecules products.

• You will represent Global CMC Regulatory Affairs on inter-disciplinary strategic projects. Moreover, you maintain up-to-date knowledge and expertise within the global CMC regulatory environment (ICH, FDA, EMA, PMDA, China and Emerging Markets).

• In addition, you will drive acceleration and innovative regulatory strategies.

Global management of CMC regulatory tasks and responsibilities in development:

• You will represent the department in global project teams and provide CMC regulatory advice regarding global regulatory requirements, CMC submission strategies and opportunities for seeking scientific advice from health authorities.

• Moreover, you will guide project teams to prepare high quality global registrations documents and response to health authority requests and ensure that timelines will be met.

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

• Furthermore, you will review CMC documentation for in-licensing products.

Global management of CMC regulatory tasks and responsibilities during product life cycle:

• You will represent the department in global project teams and provide regulatory advice regarding global CMC regulatory requirements, CMC submission. strategies and opportunities for seeking scientific advice from health authorities.

• You will guide project teams to prepare high quality global registrations documents and responses to health authority requests.

• You will plan, define, review and compile global Module 3 documentation for post approval CMC activities (e. g. CMC changes and renewals).

Requirements

• Master’s degree in life science disciplines like Pharmacy, Chemistry, or Biology or comparable field

• Global CMC regulatory experience in small molecules as well as drug-device combination products

• Experience in CMC development, pharmaceutical production, quality control or quality assurance

• Sound scientific understanding of drug development

• Ability to lead and motivate people in cross-functional teams, set directions and manage changes

• Inter-disciplinary, innovative and strategic thinking

• Strong organizational and communication skills, excellent prioritization and time management skills

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

Ready to contact us?

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

Recruitment process:

Step 1: Online application - application deadline is 28th of May, 2024

Step 2: On-site interviews beginning of end of May, 2024

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.