Boehringer Ingelheim · 19 hours ago
Director/Senior Associate Director, Global Regulatory Affairs CMC
Ridgefield, CT
Full-time
Remote
Mid, Senior Level, Lead/Staff, Director/Executive
$135K/yr - $350K/yr
6+ years exp
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Responsibilities
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)
Qualification
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Required
Minimum BS/BA Chemistry, Biology, Pharmaceutical Science or relevant field of study.
With BS/BA: Min ten (10) years’ regulatory work experience in pharma industry, FDA, or equivalent experience required.
With M.S.: Min eight (8) years’ work experience in pharma industry, health authorities or equivalent experience required.
With Ph.D.: Min six (6) years’ work experience in pharma industry, health authorities, or equivalent experience required.
Work experience in NCE/NBE CMC related Development, and/or Pharmaceutical Production, and/or QA/QC.
Profound communication and negotiation skills.
Exceptional skill in planning, organizing, decision making and problem solving.
Profound interpersonal and management skills.
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.
Preferred
An advanced degree is preferred.
Company
Boehringer Ingelheim
Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.
Founded in 1885Ingelheim Am Rhein, Rheinland-Pfalz, DEU
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Christian Eckermann
SVP, Head of Biopharma Austria
Clive Wood
Senior Vice President
Recent News
2024-10-24
MarketScreener
2024-10-14
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